Including - DialMedicali
Contents
1. TRIGEN META NAIL Retrograde Femoral Nail System Including TRIGEN SURESHOT Distal Targeting System GIS AU Te 2 Implant specifications o oo ee ec ceccesccesccssccsecsscessecssccsssesescsesesesesesseeseeestesseesseeasents 4 Surgical technique PANE POSTION SR esta teeonides 5 incision and entry s en 12 Entry point Entry portal acquisition 13 rA e a 14 Alternative technique Entry portal 14 FC UMS e ee 16 Reducer 21916 H 17 Implant measurement 17 USM heee 18 Reamed Iechnidue iii 19 NTE n eU 21 Nail insertion iii 27 Check nail CDI nement en 28 Locking screw SSSR eee 35 POG NS SCO T EE EEEE 35 DORE area E EE EE A EEE A E E S 36 OA OCR 36 Blocking screw technique Iezen AR En s e 44 251 WOMAN e 44 AP blocking screw insertion 45 ML blocking screw insertion 46 Blocking screw insertion With reducer 47 Stability blocking screw insertion 48 NO SDS SON EAA E E E E 49 Nail extraction Optional Standard technique iii 51 Percutaneous Iechnidue 51 Guide rod jamming technique 52 Catalog OA OR creer toto eee eee een ente eee ere 53 Nota Bene The technique description herein is made available to the healthcare professional to illustrate the authors suggested treatment for the uncomplicated procedure In the final analysis the preferred treatment is that which addresses the needs of the patient Indications The TRIGEN META NAIL2. Cannulated Impactor Long 7163 1185 and introduce the extraction assembly into the end of the nail Remove the remaining distal locking screw and then extract the nail with a back slapping motion using the Slotted Hammer Percutaneous technique This technique assumes the absence of a Nail Cap or Nail Cap Set Screw Remove all proximal locking screws and all but one of the distal locking screws as previously described Under fluoroscopy insert a 3 2mm Tip Threaded Guide Wire 7163 1690 into the end of the nail on power or by hand Make a 2cm incision around the Wire and advance the 12 5mm Entry Reamer over the Wire and into the end of the nail to remove any bony ingrowth Thread the Cannulated Impactor Medium or Cannulated Impactor Long 7163 1185 into the back of the Disposable Nail Extractor 7163 1320 and then thread the assembly into the end of the nail Remove the remaining distal locking screw and then extract the nail with a back slapping motion Note The tip of the Entry Reamer is straight for approximately 1cm before flaring out It is this portion of the Entry Reamer that enters the top of the nail The Cannulated Impactor Long is located in the original TRIGEN Instrument Set 7163 1326 The Disposable Nail Extractor 7163 1320 is interchangeable with the Large Nail Extractor located in the original TRIGEN Instrument Set 7163 1326 and the HFN Instrument Set 7170 0001 51 Guide rod jamming techniqu
3. near cortex Positioning of the screw can be verified with the C Arm Repeat with other distal screws Note Remove probe before proceeding to proximal locking by detaching the set stop bolt and pulling the probe by the set stop Do not pull the cable to remove the probe 33 Instruments for standard dynamic and compression locking Nail Cap Set Screw Cat No 7165 6000 Screw Length Sleeve Cat No 7167 4085 META NAIL Anterior Drop Cat No 7165 4501 Rd E hn T j Medium Hexdriver Cat No 7163 1066 Mini Connector Cat No 7163 1186 4 0mm Drill Sleeve P Cat No 7167 4083 Lig Eee 9 0mm Drill Sleeve Cat No 7163 1152 Screwdriver Release Cat No 7167 4084 4 0mm Long Pilot Drill Cat No 7163 1110 Universal META NAIL Compression Driver Cat No 7165 4528 4 0mm Short Drill Cat No 7163 1117 T handle Cat No 7167 4076 i Screw Depth Gauge Cat No 7163 1189 4 0mm Long Pilot Drill 7163 1110 is interchangeable with 4 0mm AO Long Drill 7163 1121 4 0mm Short Drill 7163 1117 is interchangeable with 4 0mm AO Short Drill 7163 1123 34 Locking screw measurement There are three methods 1 Gold 9 0mm Drill Sleeve silver 4 0mm Drill Sleeve and 4 0mm Long Pilot Drill 2 Screw Depth Gauge 7163 1189 3 Long Screw Length Sleeve 7165 4520 and 4 0mm Long Pilot Drill Locking screw insertion Distal locking options include three statically
4. within the distal femur The notch at the nail drill guide junction will be visible in the lateral Each gauge on the insertion barrel represents a 10mm depth interval Proximal In the AP view confirm that the nail has been inserted to the desired depth Femoral fractures should be treated with the longest nail possible in order to reduce the likelihood of stress risers Remove the guide rod once the nail has been fully seated and attach the Anterior Drop Note Following nail insertion confirm that the nail and drill guide are securely connected as hammering can loosen the Guide Bolt 28 Devices to lock distally ZY smith amp nephew TRIGEN SURESHOT Distal Targeting System TRIGEN SURESHOT Targeter e lt Cat No 7169 2801 Trauma Interface Cat No 7169 2802 RE EE Power Cord AO Drill Bit Short Cat No 6680 0193 Cat No 7169 2810 AO Drill Bit Long Cat No 7169 2811 mn Drill Sleeve Long Cat No 7169 2804 Hexdriver he Cat No 7169 2809 Drill Sleeve Short Cat No 7169 2805 META NAIL Standard Drill Guide Probe META Set Stop Cat No 7169 2814 Cat No 7169 2806 Note When the Targeter is out of the preferred range or there is metal or electrical interference the green and red Targeter circles on the Trauma Interface screen may become unstable and or a warning message will be displayed If the interference is excessive the IM nail image on the Tr
5. META NAIL Extension Drill Guide Cat No 7165 4503 Extension Guide Bolt 23mm pol Cat No 7165 4505 Guide Bolt Long 51mm ib Cat No 7165 4506 META NAIL Instrument Case Cat No 7165 4551 META NAIL Instrument Lid Cat No 7165 4550 Long Screw Length Sleeve Cat No 7165 4520 Cannulated Impactor Short Cat No 7165 4554 56 Instruments used if you have TRIGEN Base Set Set No 7167 4012 Medium Hexdriver Cat No 7163 1066 Short Hexdriver Cat No 7163 1068 12 5mm Entry Reamer Cat No 7163 1116 Guide Bolt Wrench Cat No 7163 1140 9 0mm Drill Sleeve Cat No 7163 1152 Multipurpose Driver Cat No 7163 1161 Mini Connector Cat No 7163 1186 Screw Depth Gauge Cat No 7163 1189 Cannulated Awl Cat No 7167 4000 Entry Portal Tube Cat No 7167 4060 3 2mm T handle Trocar Cat No 7167 4074 Honeycomb Cat No 7167 4075 Flexible Reamer Shaft Cat No 7111 8200 Reamer Heads Cat No 7111 8231 8246 57 Catalog information TRIGEN META NAIL Instruments T handle Cat No 7167 4076 Reducer Cat No 7167 4077 Obturator Cat No 7167 4078 Em Ruler Cat No 7167 4079 Gripper Cat No 7167 4080 Cannulated Impactor Medium Cat No 7167 5081 Slotted Hammer Cat No 7167 4082 4 0mm Drill Sleeve e a 08 Cat No 7167 4083 Screwdriver Release Cat No 7167 4084 Screw Length Sleeve Cat No 7167 4085 Entry Portal Han
6. Retrograde Femoral Nail is indicated for fractures of the femur including stable and unstable distal metaphyseal fractures diaphyseal fractures intraarticular fractures periprosthetic fractures nonunions malunions and for the prophylactic nailing of impending pathological fractures TRIGEN SURESHOT indications Legend Important warnings appear in orange Tips tricks and important information appear in blue Indications contraindications intended use and training The Smith amp Nephew TRIGEN SURESHOT Distal Targeting System is intended to be an intraoperative image guided localization system It is a computer assisted orthopaedic surgery tool to aid the surgeon with drill positioning for screws during intramedullary nail implantation It provides information to the surgeon that is used to place surgical instruments during surgery utilizing intraoperatively obtained electromagnetic tracking data The Smith amp Nephew TRIGEN SURESHOT Targeting System V2 0 is indicated for long bone fractures treated with intramedullary nails in which the use of stereotactic surgery may be appropriate An example of a surgical procedure includes but is not limited to locating and drilling the distal holes in an intramedullary nail Contraindications The screw targeting software application for this system is contraindicated for all IM nails other than Smith amp Nephew TRIGEN META NAIL TAN FAN Pediatric and Adolescent nails Do no
7. for opening the distal femur 3 2mm Tip Threaded Guide Wire Mini Connector Cat No 7163 1690 Cat No 7163 1186 12 5mm Entry Reamer Cat No 7163 1116 mham Honeycomb Cat No 7167 4075 E _ T handle Cat No 7167 4076 Entry Portal Tube Cat No 7167 4060 3 2mm T handle Trocar Cat No 7167 4074 Entry Portal Handle Cannulated Awl Cat No 7167 4092 Cat No 7167 4000 Incision and entry point Assemble the Honeycomb 7167 4075 Entry Portal Handle 7167 4092 and Entry Portal Tube 7167 4060 The pieces will lock in place securely at either 0 or 180 A 3 4cm midline incision is made followed by a medial parapatellar capsular incision to expose the intercondylar notch Gently retract the patellar tendon laterally The entry point is located within the intercondylar notch just anterior and lateral to the femoral attachment of the posterior cruciate ligament Entry portal acquisition Attach a 3 2mm Tip Threaded Guide Wire 7163 1690 to the drill via the Mini Connector 7163 1186 and insert 6 8cm into the distal femoral metaphysis The Entry Portal Instrumentation serves as a soft tissue protector The guide wire should be in line with the femoral axis in the AP view and anterior to Blumensaat s Line in the lateral view In the instance of suboptimal wire placement rotate the Honeycomb within the Entry Tube to the desired location and insert another 3 2mm Tip T
8. handle mm nande 4 0mm Long Pilot Drill Blocking Screw Awl Cat No 7165 4522 Cat No 7163 1110 Device Cat No 7165 4515 S 4 x 4 0mm Drill Sleeve Mini Connector Cat No 7163 1156 Cat No 7163 1186 T handle k k Cat No 7167 4076 9 0mm Drill Sleeve Cat No 7163 1152 Medium Hexdriver Cat No 7163 1066 4 0mm Long Pilot Drill 7163 1110 is interchangeable with 4 0mm AO Long Drill 7163 1121 43 Blocking screw technique Incision and entry point A 3 4cm midline incision is made followed by a medial parapatellar capsular incision to expose the intercondylar notch Gently retract the patellar tendon laterally The entry point is located within the intercondylar notch just anterior and lateral to the femoral attachment of the posterior cruciate ligament Entry portal acquisition Insert the 11 0mm T handle Awl 7165 4522 manually to a depth just distal to the fracture Note When creating the initial entry point pay close attention to the trajectory of the Awl and the relationship to the anatomic axis of the femur Correct Awl trajectory in the distal fragment must be established prior to alignment with the anatomic axis of the proximal fragment This will ensure accurate fracture reduction when the nail is inserted 44 AP blocking screw insertion In order to prevent varus or valgus malalignment of the distal fragment blocking screws may be placed in the AP plane Attach th
9. set 32cm Implant set 34cm Implant set Available through special order Cat No 7164 2225 7164 2230 7164 2235 7164 2240 7164 2245 7164 2250 7164 2255 7164 2260 7164 2265 7164 2270 7164 2275 Cat No 7165 3036 7165 3038 7165 3040 7165 3042 7165 3044 7165 3046 7165 3048 7165 3050 Length 5 0mm x 25mm 5 0mm x 30mm 5 0mm x 35mm 5 0mm x 40mm 5 0mm x 45mm 5 0mm x 50mm 5 0mm x 55mm 5 0mm x 60mm 5 0mm x 65mm 5 0mm x 70mm 5 0mm x 75mm Length Availability 36cm Implant set 38cm Implant set 40cm Implant set 42cm Implant set 44cm Outlier 46cm Outlier 48cm Outlier 50cm Outlier 5 0mm 53 Catalog information TRIGEN META NAIL Implants TRIGEN META NAIL 11 5mm Retrograde Femoral Set No 7165 1001 Cat No Length Availability Cat No Length Availability 7165 3218 18cm Outlier 7165 3236 36cm Implant set 7165 3220 20cm Outlier 7165 3238 38cm Implant set 7165 3222 22cm Outlier 7165 3240 40cm Implant set 7165 3224 24cm Outlier 7165 3242 42cm Implant set 7165 3226 26cm Outlier 7165 3244 44cm Outlier 7165 3228 28cm Outlier 7165 3246 46cm Outlier 7165 3230 30cm Implant set 7165 3248 48cm Outlier 7165 3232 32cm Implant set 7165 3250 50cm Outlier 7165 3234 34cm Implant set TRIGEN META NAIL 11 5mm Retrograde Femoral Set No 7165 1001 Cat No Length Availability Cat No Length Availability 7165 3418 18cm Outlier 7165 3436 36cm Implant set 7165 3420 20cm Outlier 7165 3438 38cm Implant set 7165
10. with 4 0mm AO Short Drill 7163 1123 The Disposable Nail Extractor 7163 1320 is interchangeable with the Large Nail Extractor 7163 1278 located in the original TRIGEN Instrument Set 7163 1326 and the HFN Instrument Set 7170 0001 60 Catalog information TRIGEN SURESHOT Instruments TRIGEN SURESHOT Targeting Interface Cat No 7165 7000 Cat No Device Case Qty 7169 2802 Trauma Interface 1 TRIGEN SURESHOT Targeting Instrument Set Set No 7165 7001 Cat No Description Tray Qty 7169 2801 Targeter 1 7169 2804 Drill Sleeve Long 2 7169 2805 Drill Sleeve Short 2 7169 2806 META Set Stop 1 7169 2807 TAN Set Stop 1 7169 2808 Field Accuracy Gauge 1 7169 2809 Hexdriver 1 7169 2816 TAN Anteversion Locking Guide 1 7169 2830 Targeting Instrument Tray 1 7169 2831 Targeting Instrument Tray Lid 1 Set No 7165 7002 Cat No Description Qty 7169 2810 AO Drill Bit Short 2 7169 2811 AO Drill Bit Long 1 Additional Disposables Cat No Description 7169 2803 META NAIL Semi Extended Drill Guide Probe afa used with TRIGEN META NAIL Semi Extended em _ Instrument Set 7165 4004 7169 2814 META NAIL Standard Drill Guide Probe used with TRIGEN META NAIL Instrument Set m s 7165 4002 7169 2815 Percutaneous TAN FAN Drill Guide Probe used with TRIGEN Percutaneous TAN FAN ee Instrument Set 7163 2351 6 TRIGEN SURESHOT Country Kit North America Cat No 7165 7003 Cat No Descripti
11. 3422 22cm Outlier 7165 3440 40cm Implant set 7165 3424 24cm Outlier 7165 3442 42cm Implant set 7165 3426 26cm Outlier 7165 3444 44cm Outlier 7165 3428 28cm Outlier 7165 3446 46cm Outlier 7165 3430 30cm Implant set 7165 3448 48cm Outlier 7165 3432 32cm Implant set 7165 3450 50cm Outlier 7165 3434 34cm Implant set Nail Cap Set Screw d Cat No 7165 6000 TRIGEN Nail Caps Cat No Length Cat No Length 7163 4000 Omm 7163 4015 15mm 7163 4005 5mm 7163 4020 20mm 7163 4010 10mm Available through special order 54 Catalog Information TRIGEN META NAIL Instruments TRIGEN META NAIL Blocking Screw Instruments Set No 7165 4001 Blocking Screw Device Cat No 7165 4515 Tibial Blocking Screw Attachment Cat No 7165 4509 11 0mm T handle Awl Cat No 7165 4522 8 5mm 10mm Blocking Screw Cartridge Cat No 7165 4511 11 5mm 13mm Blocking Screw Cartridge Cat No 7165 4513 Offset Blocking Screw Cartridge Cat No 7165 4514 Blocking Screw Alignment Pin Cat No 7165 4523 Retrograde Femoral Blocking Screw Attachment Cat No 7165 4508 Blocking Screw Instrument Case Cat No 7165 4552 Blocking Screw Instrument Lid Cat No 7165 4553 Not used in META NAIL tibial technique 55 Catalog information TRIGEN META NAIL Instruments TRIGEN META NAIL Blocking Screw Instruments Set No 7165 4002 META NAIL Anterior Drop Cat No 7165 4501 META NAIL Drill Guide Cat No 7165 4502
12. L system insertion technique 47 Stability blocking screw insertion Following nail insertion and confirmation of fracture reduction blocking screws can be placed on either side of the nail in the metaphyseal region for additional stability Screws may be inserted in both the AP and ML planes With the nail inserted attach the Retrograde Femoral Blocking Screw Attachment 7165 4508 to the Anterior Drop matching the orange shape found on the Blocking Screw Attachment to the corresponding one on the Drop Triangle to Triangle for AP screws and Square to Square for ML screws Follow the previously described technique for Cartridge positioning and blocking screw insertion Note The AP blocking screws targeted through the two 2 holes built into the Anterior Drop cannot be used if the most superior oblique distal locking screw has been inserted 48 Final view Stability blocking screws Once stability blocking screw insertion is complete remove the Blocking Screw Attachment and Anterior Drop from the drill guide and obtain both AP and lateral radiographic images to confirm accurate placement TRIGEN nail cap and nail cap Set screw insertion optional Remove the drill guide Anterior Drop assembly Attach the selected Nail Cap or Nail Cap Set Screw to the Medium Hexdriver T handle assembly and insert into the end of the nail until tight Note The TRIGEN Nail Cap does not engage with the most d
13. Proximal locking is performed in the AP plane using a free hand technique Confirm fracture reduction and align the C Arm over the desired locking hole Obtain a perfect circle image of the locking hole and use a blunt object to approximate the location of the locking hole by dimpling the skin Make a stab incision at the site insert the 4 0mm Long Pilot Drill and drill both cortices Measure for screw length using the Screw Depth Gauge Alternatively leave the 4 0mm Long Pilot Drill in place insert the Long Screw Length Sleeve down to bone and read the exposed calibrations off the drill Insert the appropriate length screw using the Medium Hexdriver T handle assembly 4 0mm Long Pilot Drill 7163 1110 is interchangeable with 4 0mm AO Long Drill 7163 1121 36 Trauma Interface screen operation Overview mode LR arog TH a Long sew When the Targeter is greater than 5cm from the interlocking holes the Trauma Interface screen will display the IM nail in the overview mode This provides the user with a larger field of view in order to help find the general location of the interlocking holes The view in the upper right corner is the profile view It is collinear to the drill sleeve axis and the position is aligned with the tip of the drill sleeve Drilling mode Gorge timm Long Saas When the Targeter is moved within 5cm of the interlocking holes the Trauma Interface screen will display the IM nail in the dril
14. auma Interface screen will disappear If interference cannot be avoided a standard X Ray technique must be used Note All tool cables should be uncoiled completely and any excess cables should be kept out of the Targeter measurement volume 29 Detach Cannulated Impactor Medium 7167 5081 from drill guide Reattach META Set Stop 7169 2806 and insert META NAIL Standard Drill Guide Probe 7169 2814 in the nail Adjust probe to nail length Skin incision Use serrated tip of Drill Sleeve to identify where to make incision The tip is at the right position when the green circle is aligned with the desired hole on screen Make incision and place tip of the drill sleeve down to bone where the green circle is aligned directly over the hole on screen Note No X Rays necessary 30 Dida O0 mm Short Soave Targeting the locking hole With the appropriate length TRIGEN SURESHOT 4 0mm Drill Bit 7169 2810 or 7169 2811 inserted into the Targeter insert the tip of the drill sleeve represented by the green circle through the incision and down to bone Perfect circles Align the tip of the drill sleeve over the desired hole in the nail This will be represented on the screen when the green circle is centered in the hole as shown Push serrated tip firmly against bone to keep the green circle static on the screen Note The orientation of the view is determined based on the orientation of the Targeter relat
15. ct the Reducer and Reducer Connector 7167 4077 so that the words Slot Orientation are in line with the opening at the tip Complete the assembly by connecting it to the T handle 7167 4076 Note If blocking screws are desired at this point in the procedure refer to the blocking screws technique section pp 43 49 Advance the Reducer into the intramedullary canal and use the curved tip to direct the 3 0mm Ball Tip Guide Rod past the fracture into the region of the proximal femur The guide rod should be center center in the AP and lateral views Reducer removal Once the guide rod is at the desired depth detach the Gripper and remove the Reducer from the femoral canal Slide the Obturator 7167 4078 into the back of the T handle during extraction in order to maintain guide rod position within the canal gt Implant measurement After Reducer removal reconfirm guide rod placement within the proximal femur and slide the Ruler 7167 4079 over the guide rod to the desired depth The metal tip of the Ruler denotes the driving end of the META NAIL Retrograde Femoral Nail Confirm guide rod position in the window at the opposite end of the Ruler as shown in order to ensure accurate implant measurement Push down on the top of Ruler until contact is made with the 3 0mm guide rod Implant length is read from the exposed calibrations at the end of the Ruler Note Implant length selection should ta
16. d long drill sleeve option selected within software Press Menu Drill Sleeve and select the short drill sleeve option and use the short drill bit Drill bit too long Long drill bit being used and short drill sleeve option selected within software Press Menu Drill Sleeve and select the long drill sleeve option and use the long drill bit 41 Problem Red and Green targeting circles representing the drill sleeve appear incorrect Targeting missed the intended hole Drill sleeve cannot be removed from TRIGEN SURESHOT Targeter The 4 7mm 4 0mm step drill will not fit through the drill sleeve Field Accuracy Check fails 42 Possible cause Incorrect drill sleeve length selected Metal interference within the TRIGEN SURESHOT electromagnetic field Probe not inserted correctly within set stop Damaged probe Metal interference within the TRIGEN SURESHOT electromagnetic field Probe not inserted correctly within set stop Damaged probe Over tightening of drill sleeve Not compatible with the TRIGEN SURESHOT Distal Targeting System Metal interference within the TRIGEN SURESHOT electromagnetic field Field Accuracy Gauge improperly installed on Targeter META Set Stop improperly installed on Field Accuracy Gauge Probe is incorrectly inserted within META Set Stop Probe is damaged Targeter is damaged Suggested action Verify the correct drill sleeve leng
17. dle Cat No 7167 4092 58 Instruments used if you have existing TRIGEN set Set No 7163 1326 Medium Hexdriver Cat No 7163 1066 Short Hexdriver Cat No 7163 1068 Gripper Cat No 7163 1100 Entry Tool Cat No 7163 1114 12 5mm Entry Reamer Cat No 7163 1116 Obturator Cat No 7163 1122 Reducer Cat No 7163 1124 Ruler Cat No 7163 1128 Guide Bolt Wrench Cat No 7163 1140 Hammer Cat No 7163 1150 9 0mm Drill Sleeve Cat No 7163 1152 4 0mm Drill Sleeve Cat No 7163 1156 Multipurpose Driver Cat No 7163 1161 T handle Cat No 7163 1172 59 Catalog information TRIGEN META NAIL Instruments Mini Connector or Cat No 7163 1186 Screw Depth Gauge Cat No 7163 1189 Screw Driver Release Handle Cat No 7163 1208 Cannulated Impactor Long pe Cat No 7163 1185 Flexible Reamer Shaft Cat No 7163 1192 Reamer Heads Cat No 7111 8231 8242 META NAIL Disposables Set No 7165 4003 4 0mm Long Pilot Drill Cat No 7163 1110 4 0mm Short Drill a Cat No 7163 1117 3 0mm x 1000mm Ball Tip Guide Rod Cat No 7163 1626 3 2mm Tip Threaded Guide Wire Cat No 7163 1690 Disposable Compression Driver Ce Cat No 7165 4517 Disposable Nail Extractor Cat No 7163 1320 4 0mm Long Pilot Drill 7163 1110 is interchangeable with 4 0mm AO Long Drill 7163 1121 4 0mm Short Drill 7163 1117 is interchangeable
18. e Advance the end of a 3 0mm Ball Tip Guide Rod through the end of the nail Insert a 2 0mm Smooth Guide Rod 7111 8280 in the same manner With both guide rods in place attach the Gripper to the end of the 3 0mm Ball Tip Guide Rod and pull it back so that it wedges the ball tip against the 2 0mm Smooth Guide Rod Backslap against the Gripper with the Slotted Hammer to extract the nail Guide rods Cat No Description 7111 8280 2 0mm x 900mm Smooth RUSSELL TAYLOR System 7111 8202 3 0mm x 900mm Ball Tip RUSSELL TAYLOR System 7163 1626 3 0mm x 1000mm Ball Tip TRIGEN System Additional removal items Cat No Description 115074 Large Extractor Hook 115073 Small Extractor Hook 914658 Large Easy Out 914659 Small Easy Out Available sterile packed For nail removal only do not use for nail insertion Located in RUSSELL TAYLOR Extraction Kit Set 7508 available through Loaners 52 TRIGEN Internal Captured Screws 4 5mm and 5 0mm Set No 7163 1321 Cat No 7164 2125 7164 2130 7164 2135 7164 2140 7164 2145 7164 2150 TRIGEN META NAIL 10mm Retrograde Femoral Length 4 5mm x 25mm 4 5mm x 30mm 4 5mm x 35mm 4 5mm x 40mm 4 5mm x 45mm 4 5mm x 50mm Set No 7165 1000 Cat No 7165 3018 7165 3020 7165 3022 7165 3024 7165 3026 7165 3028 7165 3030 7165 3032 7165 3034 Length Availability 18cm Outlier 20cm Outlier 22cm Outlier 24cm Outlier 26cm Outlier 28cm Outlier 30cm Implant
19. e Blocking Screw Device 7165 4515 to the 11 0mm T handle Awl and move it into the desired position in the AP plane Note The Blocking Screw Alignment Pins 7165 4523 can be screwed into the three 3 threaded holes on the metal handle of the Blocking Screw Device to serve as external points of reference during fracture alignment Tighten the device to the Awl and insert the appropriate Blocking Screw Cartridge 7165 4511 7165 4513 7165 4514 Adjust the Cartridge proximally or distally within the Blocking Screw Device to determine blocking screw position Insert the gold 9 0mm Drill Sleeve and silver 4 0mm Drill Sleeve into the desired cartridge hole and down to bone Drill both cortices with the 4 0 mm Long Pilot Drill Screw length is determined by reading the exposed drill bit calibrations or by removing the 4 0mm Drill Sleeve and measuring with the Screw Depth Gauge Insert the screw with the Medium Hexdriver T handle assembly until the screw engages the far cortex Note Use caution during drilling and insertion of blocking screws in the AP plane Plunging the drill bit past the posterior cortex or insertion of a screw that is too long may damage neurovascular structures located posterior to the distal femur 4 0mm Long Pilot Drill 7163 1110 is interchangeable with 4 0mm AO Long Drill 7163 1121 45 Following implantation of the distal blocking screw and fracture reduction pass the 11 0mm T handle Awl in
20. e patient s bone Note If the probe is not recognized after connection to the system the probe is i AS defective and must be exchanged See also x instrument connection Note Broken or damaged instruments must be exchanged immediately and sent back to Smith amp Nephew Inc Note This device is provided sterile by ethylene m oxide gas and is single use Red probe Blue probe Green probe Use only with Use only with Use only with META NAIL META NAIL Percutaneous Standard Drill Guide Semi extended TAN FAN Drill Drill Guide Guide 7163 1021 There will be a confirmation on the screen of the Trauma Interface that implies that the probe has H been connected Tip When oriented as shown the connector SURESHOT Probe should assemble easily Do not force the META Standard connector into the port Note If the probe is properly connected to the T system and the application reports Probe not found for more than 10 seconds the probe may be damaged or defective In this case the probe has to be exchanged Tip It is possible at any time to disconnect and reconnect tools when the application is running The display will show a screen reporting the missing instrument 22 After TRIGEN SURESHOT Targeter and probe Menu have been connected attach drill sleeve to Targeter The displayed screen will occur Select the length of the drill sleeve 7169 2804 Heese RERO or 7169 2805 tha
21. f electric shock this equipment must only be connected to a supply mains with protective earth ground Avoid spilling water or other liquids on electronic electrical equipment Use only Smith amp Nephew disposables and accessories with the Smith amp Nephew TRIGEN SURESHOT Distal Targeting System Maintenance To verify accurate functionality the device should be checked per the Maintenance Instructions contained in a separate Smith amp Nephew document 7118 1540 This accuracy check must be performed at least once every 12 months If this accuracy check is not performed as defined in the previous paragraph all warranty claims expire and the device is operated at the user s own risk Recycling Old electrical and electronic equipment must be disposed separately and may not be included in the regular domestic waste Alternatively the unit can be handed over to Smith amp Nephew Orthopaedics for correct recycling Note Do not unplug the power while the system is running Note Danger of damage and tipping over Tip Place the unit on a firm level surface capable of holding at least 10kg 22 lbs Note To avoid the risk of electric shock this equipment must only be connected to a supply mains with protective earth Devices for system set up Trauma Interface Cat No 7169 2802 Power Cord Cat No 6680 0193 TRIGEN SURESHOT Targeter Cat No 7169 2801 Note The Targeter wil
22. geter 7169 2801 to the Targeter port on the Trauma Interface Tip If the Trauma Interface does not power on make sure the switch is in the on position Note No other electrical devices should be placed near the Trauma Interface See the Guidance and Manufacturer s Declaration Separation Distances table contained in Smith amp Nephew document 7118 1540 Note The Targeter body may have contact with the patient and must remain in the sterile field at all times Only the cable and connector may be removed from the sterile field Note This step needs to be performed at least ten minutes prior to targeting in order to ensure proper accuracy Tip When oriented as shown the connector should assemble easily Do not force the connector into the port Note If the Targeter is properly connected to the system and the application remains in this screen for more than 30 seconds the Targeter may have been damaged during cleaning Sterilization In this case another Targeter has to be used Tip It is possible at any time to disconnect and reconnect tools when the application is running The display will show a screen reporting the missing instrument Targeter and probe have not been connected Menu SURESHOT Probe SURESHOT Targeter not found not found Confirmation that the Targeter tool has been connected when the center of the Targeter lights up orange SURESHOT Targeter connected Instruments
23. he information provided by the TRIGEN SURESHOT Distal Targeting System is to help the operator make decisions during the operation The operator must check all the suggestions made by the system and is responsible for all decisions taken Responsibility of Smith amp Nephew Orthopaedics In the event of improper use Smith amp Nephew accepts no responsibility or liability whatsoever for the functioning or utility of the TRIGEN SURESHOT Distal Targeting System when used in the operating theatre Cleaning and sterilization All instruments must be sterilized before use Detailed information on the cleaning and sterilization of components is contained in the separate Cleaning and Sterilization Instructions Smith amp Nephew document 7138 1339 Repair or modifications to the system The user is not permitted to modify or service the equipment There are no serviceable parts inside the unit Refer all service to authorized personnel Modifications additions to the software The user is not permitted to install or uninstall software Any new software must be installed by the manufacturer or by authorized personnel It is only allowed to connect equipment to the interface and power supply connections of the TRIGEN SURESHOT Distal Targeting System which are IEC60601 1 approved and which are approved by Smith amp Nephew Orthopaedics Do not modify this equipment without authorization of the manufacturer Electrical safety warning To avoid risk o
24. hreaded Guide Wire Blumensaat s Line Entry portal After definitive Guide Wire placement remove the Honeycomb from the Entry Tube along with any additionally inserted Guide Wires and attach the 12 5mm Entry Reamer 7163 1116 to power Advance over the Guide Wire through the Entry Tube to a depth of 6 8cm Check position via radiographic imaging and then remove the 12 5mm Entry Reamer and 3 2mm Tip Threaded Guide Wire Alternative technique Entry portal Attach the T handle 7167 4076 to the Cannulated Awl 7167 4000 and insert into the distal femur to a depth of 6 8cm Introduce the 3 2mm T handle Trocar 7167 4074 into the back of the assembly prior to insertion in order to prevent awl slippage and accumulation of cortical bone within the cannulation Cannulated Awl 3 2mm T handle with T handle Trocar Instruments for fracture reduction and reaming Entry Portal Tube Cat No 7167 4060 Entry Portal Handle Cat No 7167 4092 Ruler Cat No 7167 4079 Gripper Cat No 7163 4080 Obturator Cat No 7167 4078 kad T handle Cat No 7167 4076 Reamer Shaft Cat No 7111 8200 Reducer Cat No 7167 4077 Reamer Heads Cat No 7111 8231 8246 3 0mm Ball Tip Guide Rod Cat No 7163 1626 15 Fracture reduction Insert the back end of the 3 0mm Ball Tip Guide Rod 7163 1626 into the front of the Gripper 7167 4080 and gently close the trigger grip Conne
25. ield Accuracy Gauge insert a TRIGEN SURESHOT probe into the set stop and set the depth to the REF mark on the probe body 3 From the software Menu button select Field Check option 25 4 A software window will appear informing UE neia Check Gauge META the user if the TRIGEN SURESHOT Targeter and Probe combination is within the predefined accuracy parameters Pass or Fail message 5 If the field accuracy check fails check the Le aia Check Gauge META Troubleshooting section of this document for possible solutions Note This step should be performed at least once a year to ensure that the device is working properly 26 Nail insertion Detach wing and set stop and attach impactor Remove the Anterior Drop and attach the Cannulated Impactor Medium 7167 5081 to the drill guide Orient the drill guide assembly in the AP position and advance the nail over the guide rod by light blows from the Slotted Hammer 7167 4082 to the desired depth Additional reaming of the intramedullary canal may be necessary if excessive force is required to insert the nail Verity fracture reduction as the nail crosses the fracture site paying close attention to rotation length alignment distraction and or shortening Check final nail position in both the AP and lateral views for correct alignment 2 Check nail depth Distal In the AP and lateral views confirm nail position
26. il ML view Note These views are not to scale and should be used as a pictorial representation only Specifications TRIGEN META NAIL Retrograde Femoral Material Diameter Lengths Nail Color Cross Section Distal Diameter driving end Proximal Diameter non driving end Smallest Thru Diameter Wall Thickness Guide Bolt Thread Screw Diameter Screw Color Major Diameter Minor Diameter core Screw Lengths Hex Size Alternative Hexdrivers Alternative Modes TI6AL4V 10 11 5 amp 13mm 18 50cm Gold Round 12mm 10 11 5 dia 13mm 13 dia 10 11 5 amp 13mm 5 0mm 2 3mm 10 dia 3 0mm 11 5 dia 2 3mm 13 dia 5 16 24 UNF 5 0mm Gold 5 0mm 4 3mm 25 110mm 4 7mm RT Femoral amp Recon 7 0mm Cannulated Screw PERI LOC 4 7mm Hexdriver PROFIX 4 7mm Hexdriver No Static Lock Locations Orientations Static Locking Hole Dimensions Proximal Locking Non Driving End Static Lock Locations Orientations Static Locking Hole Dimensions Proximal Screw Hole Diameter AP Bow Radius AP Bow Location 15mm ML Threaded Can be locked with META NAIL Cap 30mm 25 Threaded w bushing 40mm 25 Threaded w bushing Threaded 4 5mm minor dia Threaded 5 3mm major dia 15mm AP 35mm AP 5 3mm 5 3mm 2M Starts 100mm from Driving End Set does not include all sizes Outlier sizes may be special order only Surgical technique Patient posit
27. ioning Position the patient supine on a radiolucent table Flex the affected limb approximately 45 over a posterior support to assist with fracture reduction Check for length and rotation by comparison to the unaffected limb Rotate the C Arm to ensure optimal AP and lateral visualization of the entire femur The C Arm should be able to freely access the femur up to and including the intertrochanteric area A distraction device may also be applied to obtain and or maintain traction Intraarticular fracture components should be addressed with interfragmentary screw fixation prior to nail insertion Care should be taken to place the screws in the anterior and posterior aspect of the distal femur and safely out of the nail s intended path Note Cannulated screw guide wires allow for confirmation of definitive screw placement prior to fracture fixation and nail insertion Use a bolster or radiolucent triangle to maintain limb position Rotate the C Arm to ensure optimal AP and lateral visualization of the entire tibia A distraction device may also be applied to obtain and or maintain traction Caution Do not use a metal bump because it will adversely affect the accuracy of the TRIGEN SURESHOT system Warnings and cautions for TRIGEN SURESHOT Accessibility of documentation Please ensure that all instructions are kept in an easily accessible place for operating personnel The operator checks and decides All t
28. istal locking screws to create a fixed angle construct Note If cross threading occurs rotate the Nail Cap or Nail Cap Set Screw counterclockwise until its threads line up with those of the nail Proceed with insertion until tight 49 Instruments for implant removal 3 2mm Tip Threaded Guide Wire Cat No 7163 1690 12 5mm Entry Reamer Cat No 7163 1116 e aa Mini Connector Cat No 7163 1186 Disposable Nail Extractor Cat No 7163 1320 Cannulated Impactor Medium Cannulated Impactor Long Cat No 7167 5081 Cat No 7163 1185 T handle Cat No 7167 4076 Medium Hexdriver Cat No 7163 1066 Additional guide rods listed on page 52 CC AT x 3 0mm x 1000mm Ball Tip Guide Rod Cat No 7163 1626 Slotted Hammer Cat No 7167 4082 The Cannulated Impactor Long is located in the original TRIGEN Instrument Set 7163 1326 The Disposable Nail Extractor 7163 1320 is interchangeable with the Large Nail Extractor 7163 1278 located in the original TRIGEN Instrument Set 7163 1326 and the HFN Instrument Set 7170 0001 50 Nail extraction optional Standard technique Remove the Nail Cap or Nail Cap Set Screw if implanted and all of the proximal locking screws with the Medium Hexdriver T handle assembly Remove all of the distal locking screws except for one in the same manner Thread the Extraction Bolt 7163 1320 into the Cannulated Impactor Medium 7167 5081 or
29. ive to the implant For example if the desired hole to target is an AP hole direct the Targeter generally on the Anterior side of the leg For more options please see section Trauma Interface Screen Operation Adjust the trajectory represented by red line between two circles of the red circle until both circles are concentric and centered with the desired hole on the screen Then start drilling Critical Verify there are no other metal objects including metal triangles in the field Metal interference will cause the system to be inaccurate ay Sa ct Girls Note The green ring must be fully within the hole of the IM nail displayed on the Trauma Interface screen to ensure accurate drilling 31 Drilling distal hole Drill through near cortex and the nail using the TRIGEN SURESHOT 4 0mm Drill Bit 7169 2810 or 7169 2811 Before drilling through far cortex obtain the screw measurement Note Important if standard 4 0mm drill from TRIGEN set is used magnetic metal can adversely affect accuracy causing the drill to miss Verify there is no other magnetic metal object in area other than the items shown A note will appear on screen warning of compromised targeting field if magnetic metal is close If it is in the field image disappears Screw measurement With the tip of the drill against the far cortex measure for length then drill through the far cortex Ensure the serrated tip of the drill sleeve i
30. ke into consideration the fact that the nail must be countersunk past the articular surface of the distal femur Note Confirm that the Ruler opens easily and adjust the thumb wheel connection at the end to allow for free movement Radiographic templating is used to determine nail size The appropriate diameter implant will provide translational fill within the isthmus of the intramedullary canal Generally selection of a nail at least 1 1 5mm less than the narrowest canal measurement on the lateral radiograph assists in avoiding implant incarceration during insertion 18 jo jo jo jo jo jo Jojo Jo A P VIEW Top of Nail 10mm 20mm 30mm 40mm 50mm 60mm 25mm Uf ee 35mm U 40mm 45mm S T 50mm mm yy 60mm 65mm Uy 70mm 75mm _ 80mm 85mm Vi 90mm 95mm ur 100mm 105mm VY 110mm 5 0mm Gold Screw Size Omm Set Screw Nail Cap a Size Omm Nail Cap Nail Cap 12mm Distal Diameter LATERAL VIEW TRIGEN META NAIL Femoral Retrograde Nail Radiographic Template Cat No 7118 0811 Reamed technique Radiographic templating and intraoperative measurement will determine nail size Beginning with the 9 0mm Front Cutting Reamer Head 7111 8231 and Flexible Reamer Shaft 7111 8200 ream the intramedullary canal sequentially in half millimeter increments to a si
31. l be operated within the Sterile field and may have contact with the skin of the patient The drill sleeve inserts will be used in the incision and have direct bone contact Note Verify that the Targeter housing is not damaged holes tears cracks If the housing or the connector is damaged the Targeter is no longer safe to use Note If the Targeter is not recognized after connection to the system the Targeter is defective and must be exchanged See also instrument connection Note Broken or damaged instruments must be exchanged immediately and sent back to Smith amp Nephew Inc Note This device is provided non sterile and must be cleaned and sterilized per Cleaning and Sterilization Smith amp Nephew document 7138 1339 prior to use Surgical procedure OR preparation Note This procedure will cover only the specific steps of freehand targeting of intramedullary locking holes using the TRIGEN SURESHOT Distal Targeting System For the full surgical procedure please refer to the specific surgical technique for the TRIGEN IM Nail System being implanted Trauma Interface setup After the sterile areas have been established place the Trauma Interface 7169 2802 in the desired non sterile location and turn on the power switch Pressing the power button will bring up the start up screen Mier TRIGEN SURESHOT Targeter connection When the display prompts for tool connections connect the TRIGEN SURESHOT Tar
32. lable on C Arm machines Implant _ Menu When choosing an implant several options are given Tap on screen to select eee Drill sleeve _ Menu Tap on screen to select appropriate drill sleeve E aa 38 Field check Fail screen meaning that something is not targeting correctly See Troubleshooting section for further information Pass screen When targeting correctly a pass screen will occur About The About screen provides more information about the software used Shutdown Tap on screen to shut down the system before flipping the power switch 39 Error message Menu An error message will occur if a probe sensor is SURESHOT Targeter invalid or broken bald or broken sensor please exchange Distal blocking screws with Mew perearoade 10 mm TRIGEN SURESHOT The white lines displayed on either side of the IM nail can be used for targeting blocking screws These lines are located 2 5mm trom the side of the IM nail for all IM nails 10mm and larger in diameter These lines are located 2mm from the sides of 8 5mm IM nails 40 Problem Possible cause Suggested action Trauma Interface unit is without power Mains power plug is not inserted properly or there is no mains power Insert mains power plug into reliable power supply No power on the wall outlet Try other power outlet One or both mains power fuses are bl
33. ling mode This provides the user with a smaller field of view that automatically zooms in to the interlocking holes The white lines displayed on either side of the IM nail can be used for targeting blocking screws These lines are located 2 5mm from the side of the IM nail for all IM nails 10mm and larger in diameter These lines are located 2mm trom the sides of 8 5mm IM nails Drilling mode manual rotation LD ro meen rest Ro Each IM nail has several predefined views that are automatically selected depending on the position of the Targeter to the IM nail Depending on the operating environment these predefined views might not be appropriate and can be manually adjusted To rotate the view Touch the screen near the outside and drag the view in a clockwise or counterclockwise direction To flip the view Mow ee Sent ee Touch the Menu button and select Toggle Back View All changes made for a view are temporarily stored for that view until program exit To reset the view The default view settings can be restored by touching the Menu button and selecting Reset View or double tapping the center of the screen 37 Menu Options Menu Tapping on the Menu button will open up several Menu options Toggle back view This view may be used in cases where the Trauma Interface cannot be placed in front of the surgeon It is intended to be used similar to the mirror option commonly avai
34. locked threaded holes that are targeted through the orange and green color coded holes on the Anterior Drop Proximal locking options include two statically locked nonthreaded AP holes Gold 5 0mm locking screws are compatible with 10 11 5 and 13mm diameter nails Note The 4 0mm Short Step Drill 7164 1123 may be used to drill for a gold 5 0mm locking screw in the instance of hard cortical bone The 4 7 4 0mm width transition facilitates easier screw insertion without compromising purchase 4 0mm Long Pilot Drill 7163 1110 is interchangeable with 4 0mm AO Long Drill 7163 1121 35 Note Make sure to remove probe before proximal locking Distal locking without the use of TRIGEN SURESHOT Make a small incision at the site of screw entry and insert the gold 9 0mm Drill Sleeve and silver 4 0mm Drill Sleeve through the desired slot on the Anterior Drop down to bone Drill both cortices with the 4 0mm Long Pilot Drill Measure for screw length using either the calibrations on the 4 0mm Long Pilot Drill or by removing the 4 0mm Drill Sleeve and using the Screw Depth Gauge Attach the appropriate length screw to the end of the Medium Hexdriver 7163 1066 and insert through the gold 9 0mm Drill Sleeve on power until the laser etched ring on the Hexdriver reaches the back of the Drill Sleeve Attach the T handle to the Hexdriver and tighten the screw by hand Proximal locking without the use of TRIGEN SURESHOT
35. on Qty 6680 0193 Power Cord 125 Volt 10 Amp North 1 America Hospital Grade 7118 1540 User Manual English 1 Additional country kits TRIGEN SURESHOT Country Kit Australia Cat No 7165 7004 Cat No Description Qty 6680 0303 Power Cord 250 Volt 10 Amp 1 Australia NZ 7118 1540 User Manual English 1 TRIGEN SURESHOT Country Kit Continental Europe Cat No 7165 7005 Cat No Description Qty 6680 0291 Power Cord 250 Volt 10 Amp 1 Continental Europe 7118 1540 User Manual English 1 TRIGEN SURESHOT Country Kit Germany Cat No 7165 7006 Cat No Description Qty 6680 0291 Power Cord 250 Volt 10 Amp 1 Continental Europe 7118 1538 User Manual German 1 TRIGEN SURESHOT Country Kit Spain Cat No 7165 7007 Cat No Description Qty 6680 0291 Power Cord 250 Volt 10 Amp 1 Continental Europe 7118 1539 User Manual Spanish 1 62 TRIGEN SURESHOT Country Kit France Cat No 7165 7008 Cat No Description Qty 6680 0291 Power Cord 250 Volt 10 Amp 1 Continental Europe 7118 1537 User Manual French 1 TRIGEN SURESHOT Country Kit Italy Cat No 7165 7009 Cat No Description Qty 6680 0291 Power Cord 250 Volt 10 Amp 1 Continental Europe 7118 1536 User Manual Italian 1 TRIGEN SURESHOT Country Kit United Kingdom Cat No 7165 7011 Cat No Description Qty 6680 0213 Power Cord 250 Volt 10 Amp UK 1 7118 1540 User Manual English 1 TRIGEN SURESHOT Coun
36. on and nail length match align the drill sleeve with one of the distal holes of the nail Verify on the display that the representation of the nail drill sleeve is true Remove the probe from inside the nail and begin nail insertion Take off set stop before inserting the nail and place the impactor Note Verify the probe is oriented correctly in the set stop notches should face anteriorly If the probe is rotated 180 it will not be accurate Note The probe is bent for easier insertion Do not straighten it as this may cause inaccuracy or even missing the lock Note All tool cables should be uncoiled completely and any excess cables should be kept out of the Targeter measurement volume Note To guarantee system accuracy the accuracy check has to be performed directly in the operative field hey eT ee 24 Field accuracy check optional A field accuracy check procedure should be performed at least once a year or whenever the accuracy of a TRIGEN SURESHOT probe or TRIGEN SURESHOT Targeter needs to be verified This procedure can also be performed during surgery to verify all components are working correctly prior to their use on a patient Field accuracy check steps Attach TRIGEN SURESHOT Field Accuracy Gauge 7169 2808 to TRIGEN SURESHOT Targeter The knob on the Field Accuracy Gauge should be hand tightened only N Attach the TRIGEN SURESHOT META Set Stop 7169 2806 to the end of the F
37. own Replace mains fuses Buttons or items are difficult to select on the touchscreen Touchscreen is de calibrated Access Calibration software by selecting Maintenance from the About option under the Menu options password required VGA video out not functioning VGA port not activated on Trauma Interface Connect VGA cable to both Trauma Interface and video monitor before powering on Trauma Interface Damaged VGA cable Replace VGA cable Video monitor not on correct input Select proper input on video monitor TRIGEN SURESHOT Targeter not recognized Error reading data from Targeter Unplug Targeter wait 10 seconds plug back in Damaged Targeter Replace Targeter with new unit Probe not recognized Error reading data from probe Unplug probe wait 10 seconds plug back in Damaged probe Replace probe with new unit Probe will not insert to the proper depth in the nail Obstruction within the nail cannulation Re insert the ball tip guide rod into the nail cannulation to clear any obstruction Nail not visible on the screen Metal interference Remove any metal objects from within the TRIGEN SURESHOT the targeting field electromagnetic field TRIGEN SURESHOT Targeter Move the TRIGEN SURESHOT and probe not within range of Targeter closer to the sensor each other end of the probe Drill bit too short Short drill bit being used an
38. s pushed against the bone Example Measure 35mm add approximately 5mm the screw length would be 40mm Alternative screw measurement with depth gauge 7163 1189 After successfully drilling through the screw hole of the nail with the TRIGEN SURESHOT 4 0mm Drill Bit remove the drill bit being careful not to move the leg 32 Screw insertion Detach drill sleeve from Targeter Introduce Hexdriver with the screw attached through Targeter TRIGEN SURESHOT Targeter is backed away from bone by sleeve length approximately 80mm for the short sleeve Note Image disappears if too close Note The standard TRIGEN Hexdrivers are made trom magnetic stainless steel that will cause interference with the system and cannot be used Insert the bone screw into the pre drilled hole through the nail and through the far cortex Note For 10 11 5 13mm nails use TRIGEN Internal Captured Screws 5 0mm gold for 8 5mm nails use TRIGEN Internal Captured Screws 4 5mm grey Before fully inserting the screw remove power drill and Targeter Final screw seating must be done by hand by attaching the T handle 7167 4076 to the Medium Hexdriver 7163 1066 The depth of the screw can be verified by placing a gold 9 0mm Drill Sleeve 7163 1152 down to bone over the hexdriver There is a profile of the screw head and a groove on the hexdriver that may be used as an indicator for the position of the screw head relative to the
39. s the A on the insertion barrel The apex of the nail s AP Bow and the drill guide itself are oriented anterior The bevel on the front of the nail marks the connection to the drill guide and can be seen in the lateral view as a means for determining distal insertion depth Note Do not use the META NAIL Extension Drill Guide to insert the Retrograde Femoral Nail as the Insertion Barrel is too short to allow for adequate countersinking of the nail It is recommended to use the standard drill guide and Long Guide Bolt due to the longer Insertion Barrel Attach the Anterior Drop 7165 4501 to the drill guide and verify targeting accuracy by inserting a gold 9 0mm Drill Sleeve 7163 1152 and silver 4 0mm Drill Sleeve 7167 4083 into the Drop and passing a 4 0mm Long Pilot Drill 7163 1110 through the assembly An incorrectly attached nail will not target Note See page 25 for the field accuracy check with the TRIGEN SURESHOT Distal Targeting System 4 0mm Long Pilot Drill 7163 1110 is interchangeable with 4 0mm AO Long Drill 7163 1121 21 system setup Connect probe to Trauma Interface unit Make sure to use the adequate probe with the correct nail color coded Connect the probe to either of the probe sensor ports on the Trauma Interface Note For assembly screw on set stop to drill guide then insert probe Note The probe will be used as an intramedullary tool inside the nail placed in th
40. t operate the TRIGEN SURESHOT Targeter within 200mm of an installed pacemaker The magnetic field produced by the Targeter may interfere with the operation of the pacemaker Intended use The TRIGEN SURESHOT Distal Targeting System is only designed for use with the indicated implants and instruments Implants and instruments must be used in accordance with the instructions as described in this manual and or in the non navigated surgical procedure Training Only trained operators are allowed to use the TRIGEN SURESHOT Distal Targeting System The various operating instructions must be fully read and understood as part of the training If any part of the instructions is unclear please contact your local representative Plausibility check As with all technical equipment malfunctions may occur due to improper use or more rarely technical failure To reduce the risks involved with such technical malfunction the operation can be completed using manually controlled instruments providing the malfunction is detected without delay It is therefore important to check the plausibility of the steps as indicated by the system and to carry out verification of the software targeting particularly when using the system for the first time Should there be any doubt regarding correct functioning the targeting should be verified or a switch made to a traditional X Ray technique Non driving end of nail Top view of nail Driving end of na
41. t will be used Generally the short sleeve is sufficient In some cases using the femoral retrograde technique the long sleeve needs to be used Tip A different sleeve can be selected at any time during the procedure by choosing the drill sleeve option from the drop down menu after the implant has been selected The selected sleeve will be noted on the Trauma Interface screen Drill sleeve attachment Tightly secure the selected drill sleeve to Tip The drill sleeve 7169 2804 and 7169 2805 the Targeter can be loosened from the Targeter using the slot in the TRIGEN Slotted Hammer 7167 4082 Select the TRIGEN IM nail and size that will Menu be used Tip A different TRIGEN IM nail and or size can be selected at any time during the procedure by choosing the Implant option from the drop down menu The selected implant and diameter will be noted on the Trauma Interface screen ee ooo 23 Locking hole accuracy check in the operative field Insert the probe with the assembled set stop through the drill guide and cannulation of the TRIGEN IM nail Tip The Guide Bolt Wrench 7163 1140 may be Note The TRIGEN SURESHOT Distal Targeting used as a lever to release the set stop from the System cannot be used with the Standard drill guide if overtightened TRIGEN Drill Guide 7163 1134 Ensure that the probe is oriented correctly and the set stop position and IM nail length match Note Verify the set stop positi
42. th is selected trom the software menu Remove any metal objects from the targeting field Verify probe is oriented and seated correctly in the notches of the set stop Verify probe accuracy with Field Accuracy Gauge Remove any metal objects from the targeting field Verify probe is oriented and seated correctly in the notches of the set stop Verify probe accuracy with Field Accuracy Gauge Use the Slotted Hammer from the instrument tray as a wrench to unscrew the drill sleeve counter clockwise from the Targeter Only use the long 7169 2811 and short 7169 2810 drills designated for use with the TRIGEN SURESHOT Distal Targeting System Remove any metal objects from the targeting field Verify Field Accuracy gauge is fully seated within Targeter port and knob is hand tightened to Targeter Verify META Set Stop is correctly oriented and tightened securely to Field Accuracy Gauge Verify probe is oriented properly and inserted to the REF notches on probe body Replace probe with a new probe Replace Targeter with a new Targeter and return old one for service Instruments for blocking screw insertion 8 5mm 10 0mm 11 5mm 13 0mm Offset Blocking Screw Cartridge Screw Cartridge Screw Cartridge Cat No 7165 4511 Cat No 7165 4513 Cat No 7165 4514 Retrograde Femoral san T _ Blocking Screw Blocking Screw Alignment Pin Attachment Cat No 7165 4523 Cat No 7165 4508 11 0mm T
43. to the proximal fragment Reposition either the Blocking Screw Cartridge or the Awl as necessary and follow the previously described technique for blocking screw insertion ML blocking screw insertion In order to prevent anterior or posterior malalignment of the distal fragment blocking screws may also be placed in the ML plane Attach the Blocking Screw Device to the 11 0mm T handle Awl and rotate it into the desired position in the ML plane Tighten the device to the Awl and insert the appropriate Blocking Screw Cartridge Adjust the Cartridge proximally or distally within the Blocking Screw Device to determine blocking screw position Blocking screw insertion follows the previously described technique 46 Blocking screw insertion with reducer Blocking screw insertion can also be performed by attaching the Blocking Screw Device to the Reducer instead of the 11 0mm T handle Awl Blocking screw insertion follows the previously described technique Final view AP and ML blocking screw insertion Once blocking screw insertion is complete remove the Blocking Screw Device from the 11 0mm T handle Awl or Reducer and obtain both AP and lateral radiographic images to confirm accurate placement The Awl or Reducer provides a good indication of the nail s insertion trajectory based upon the location of the blocking screws Following confirmation of proper screw placement proceed with nail insertion following the META NAI
44. try Kit South Africa India Cat No 7165 7012 Cat No Description Qty 6680 0302 Power Cord 250 Volt 10 Amp 1 So Africa India 7118 1540 User Manual English 1 63 Notes 64 Orthopaedics Smith amp Nephew Inc www smith nephew com 1450 Brooks Road Memphis TN 38116 USA Telephone 1 901 396 2121 Information 1 800 821 5700 Orders Inquiries 1 800 238 7538 2010 Smith amp Nephew Inc All rights reserved Trademark of Smith amp Nephew Certain marks Reg US Pat amp TM Off 7118 1613 REVO 2 03 10
45. ze 1 1 5mm larger than the selected nail size Ensure guide rod placement during reaming by inserting the Obturator into the back of the Reamer unit during retraction Continue to confirm Guide Rod placement in the proximal femur throughout reaming Periodically move the Reamer back and forth in the canal to clear debris from the cutting flutes Instruments for nail assembly and insertion Guide Bolt Wrench Cat No 7163 1140 META NAIL Anterior Drop Cat No 7165 4501 9 0mm Drill Sleeve Cat No 7163 1152 META NAIL Drill Guide Cat No 7165 4502 4 0mm Drill Sleeve Cat No 7167 4083 Guide Bolt Long Cat No 7165 4506 4 0mm Long Pilot Drill Cat No 7163 1110 Cannulated Impactor Short Cat No 7165 4554 Cannulated Impactor Medium Cat No 7167 5081 Slotted Hammer T handle Cat No 7167 4082 Cat No 7167 4076 p META NAIL Standard Drill Guide Probe META Set Stop Cat No 7169 2814 Cat No 7169 2806 Guide Bolt Wrench Cat No 7163 1140 4 0mm Long Pilot Drill 7163 1110 is interchangeable with 4 0mm AO Long Drill 7163 1121 20 N io Nail assembly Attach the META NAIL Drill Guide 7165 4502 to the nail with the Guide Bolt Long 7165 4506 and tighten with the Guide Bolt Wrench 7163 1140 and T handle The nail is correctly aligned when The line on the insertion barrel matches the line on the back of the nail The A on the nail matche
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