TRIGEN™ META-NAIL™ Instruments
Contents
1. 4 0mm Long Pilot Drill 4 0mm Short Drill Cat No 7163 1110 Cat No 7163 1117 w Screwdriver Release T handle Cat No 7167 4084 Cat No 7167 4076 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 30 a oOo N Locking screw measurement There are three methods Gold 9 0mm Drill Sleeve silver 4 0mm Drill Sleeve and 4 0mm Long Pilot Drill Screw Depth Gauge 7163 1189 Screw Length Sleeve 7167 4085 and 4 0mm Short Drill 7163 1117 Locking screw insertion Proximal locking options include three statically locked threaded holes and one slot that allows for both fracture compression and or dynamization These are targeted through the orange and blue color coded holes on the Anterior Drop Distal locking options include three statically locked holes two ML and one AP The most distal ML hole is threaded for additional stability Gold 5 0mm locking screws are compatible with 10mm 11 5mm and 13mm diameter nails and grey 4 5mm locking screws with 8 5mm diameter nails Note Do not use the 4 0mm Short Step Drill 7164 1123 when drilling for a grey 4 5mm locking screw Its diameter transitions from 4 0mm to 4 7mm and will drill too large a hole in the near cortex This may compromise locking screw purchase Final image of the META NAIL Tibial Nail wit2. Note If nail is left in dynamic mode a nail cap cannot be used as it will push against the locking screw 4 0mm Long Pilot Drill 7163 1110 is interchangeable with 4 0mm AO Long Drill 7163 1121 32 Proximal locking Compression There are two 2 methods Compression Driver method 1 Countersink the nail a minimum of 10mm and lock the nail distally 2 Reduce the fracture as much as possible to maximize the advantage of the compression driver 3 Insert a screw through the proximal side of dynamic slot as previously described 4 Remove the gold 9 0mm Drill Sleeve and Medium Hexdriver 5 Attach the Universal Compression Driver 7165 4528 to the T handle and thread it through the guide bolt into the top of the nail until it contacts the most proximal 5 0mm locking screw 6 Advance the Compression Driver clockwise to drive the locking screw distally which will compress the fracture up to 7mm 7 Once the fracture gap is adequately compressed lock the nail with up to three additional proximal static screws while the Anterior Drop is still attached to the drill guide Nail Cap Set Screw method Lock the nail distally fully insert the dynamic locking screw as previously described and remove the Drill Guide Anterior Drop assembly Insert the Nail Cap Set Screw 7165 6000 into the top of the nail and advance with the Medium Hexdriver T handle assembly until the fracture is compressed and the Nail Cap Set Screw has
3. TRIGEN META NAIL Semi extended Instrument Set Including TRIGEN SURESHOT Distal Targeting System E RSS SI b K So R MACION DANDO RS ene RIR eee 2 Implant specifications eretas 4 Surgical technique Patient POSMONINE a me 5 Incision and entry point isse o dede 10 Entry portal acquisition eretas 11 OO open Rr er 12 Alternative technique Entry portal 000 0 ccc cc cccceccssceseesesereeneees 12 Fracture reduction ae ares 14 Reducer SON tk a 14 Implant M ASUT MENL nie ners 15 Unreamed echnigue ereta 16 Reamed technique 17 Nail eO 19 NELAS SOR ccc en nteteeeremmearasaneenene 23 Check nail deth 24 ITOWNS E EE 29 Locking screw measurement 31 Locking screw insertion 31 Proximal locking Static 32 Proximal locking Dynamic 32 Proximal locking Compression e 33 Nail extraction Optional Standard technique 35 Percutaneous Technique 35 Guide rod jamming technique 36 Catalog information eee 37 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 analvsis the preferred treatment is that which addresses the needs of the patient The technique is based on the tibial nailing approach outlined in the article below Tornetta P 3rd Collins E Semiextended position of intramedullarv nailing of the
4. Confirm that the tool connection has been verified Blue probe Note When oriented as shown the connector should oe assemble easily Do not force the connector into the META NAIL Semi i me extended Drill Guide port Simply try rotating the connector until the keys are 7169 2803 oriented in the 12 oclock position Note If the probe is properly connected to the system and the application reports Probe not found for more than 10 seconds the probe may be damaged or Set the probe to the length of the TRIGEN IM Nail defective In this case the probe has to be exchanged Note 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 20 Surgical procedure after IM Nail Assembly to the Drill Guide Drill sleeve selection Select the length of the drill sleeve 7169 2804 7169 2805 or 7169 1165 and 7169 1166 that will be used A different sleeve can be selected at any time during the procedure by choosing the drill sleeve option from the drop down menu OR by pressing the drill sleeve tab located in the lower right corner of the navigation screen Implant selection screen Select the TRIGEN IM Nail and size that will be used META NAIL Note 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 OR by pressing the
5. Mini Connector a fee Cat No 7163 1186 Screw Depth Gauge Cat No 7163 1189 Screw Driver Release Handle Cat No 7163 1208 Cannulated Impactor Long gem rs Cat No 7163 1185 l a r iddes ddh E cd dia do LEMA ES US ERARE 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 85s Cat No 7163 1117 3 0mm x 1000mm Ball Tip Guide Rod Cat No 7163 1626 3 2mm Tip Threaded Guide Wire ees Cat No 7163 1690 Universal Compression Driver To e Cat No 7165 4528 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 Omm Short Drill 7163 1117 is interchangeable with 4 0mm AO Short Drill 7163 1123 xxx 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 44 Catalog information TRIGEN SURESHOT Instruments TRIGEN SURESHOT Targeting Interface Cat No 7165 7000 Cat No Device Case Qty 7169 2802 Trauma Interface TRIGEN SURESHOT Targeting Instrument Set Set No 7165 700 Cat No Description Tray Qty 7169 2801 Targeter 7169 2804 Drill Sleeve Long 2 7169 2805 Drill Sleeve S
6. amp Nephew TRIGEN SURESHOT Targeting System 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 al IM nails other than Smith amp Nephew TRIGEN META NAIL TANT FAN Humeral Pediatric and Adolescent nails Do not 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 Smith amp Nephew 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 th
7. fully engaged the locking screw Note If the Compression Driver is progressed after the fracture is fully compressed then the locking screw will begin to bend In extreme cases where excess force is applied the screw may break upon removal Note For additional information on Blocking Screws reference the TRIGEN META NAIL Tibial Nail Surgical Technique 33 Instruments for implant removal 3 2mm Tip Threaded Guide Wire Cat No 7163 1690 12 5mm Entry Reamer Cat No 7163 1116 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 3 0mm x 1000mm Ball Tip Guide Rod Cat No 7163 1626 Slotted Hammer Cat No 7167 4082 T handle Cat No 7167 4076 Medium Hexdriver Cat No 7163 1066 Additional Guide rods listed on page 46 x 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 34 Nail extraction optional Standard technique Remove the Nail Cap or Nail Cap Set Screw if implanted and all of the distal locking screws with the Medium Hexdriver T Handle assembly Remove all of the proximal locking screws except for one i
8. 16 Reamed technique Radiographic templating and intraoperative measurement will determine nail size Beginning with the 9 0mm End Cutting Reamer Head 7111 8231 and Flexible Reamer Shaft 7111 8200 ream the intramedullary canal sequentially in half millimeter increments to a size 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 distal tibia 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 META NAIL Anterior Drop Cat No 7165 4501 Guide Bolt Wrench Cat No 7163 1140 pe 8 9 0mm Drill Sleeve Cat No 7163 1152 4 0mm Drill Sleeve Cat No 7167 4083 4 0mm Long Pilot Drill Cat No 7163 1110 Cannulated Impactor Short Slotted Hammer Cat No 7165 4554 Cat No 7167 4082 T handle Cat No 7167 4076 META Set Stop Cat No 7169 2806 Semi extended Drill Guide Cat No 7165 4524 Semi extended Guide Bolt Cat No 7165 4525 Impactor Cat No 7167 5081 META NAIL Semi Extended Drill Guide Probe Cat No 7169 2803 Nail assembly Attach the META NAIL Semi extended Drill Guide 7165 4524 to the nail with the Guide Bolt 7165 4525 and tighten with the Guide Bolt Wrench 7163 1140 and T
9. 5 amp 13mm 16 50cm Gold Round 12mm 10 11 5 dia 13mm 13 dia 10 11 5 amp 13mm 5 0mm 2 3mm 10 3 0mm 11 5 2 3mm 13 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 locations orientations Static Locking Hole Dimensions Compression Dynamic Slot Location Compression Dynamic Slot Diameter Length Degree of Proximal Bend Herzog Proximal Bend Location Static Lock Locations Orientations Static Locking Hole Dimensions Degree of Distal Bend Distal Bend Location 17mm 45 Screw Locked w META NAIL Cap 23mm 45 Threaded w bushing 30mm 25 Threaded 40mm 25 Threaded Threaded 4 3mm minor dia Threaded 4 7mm major dia 10mm 4 7mm 7mm 10 Threaded 4 5mm minor dia Threaded 5 3mm maior dia 10mm 5 3mm 7mm 10 27mm 25mm ML 15mm AP 5mm ML Threaded 4 7mm 79 60mm Set does not include all sizes Most distal hole threaded 25mm ML 15mm AP 5mm ML Threaded 5 3mm 29 60mm Surgical Technique Patient positioning Position the patient supine on a radiolucent table with the unaffected limb extended away from the affected limb There should be approximately 10 20 of flexion 2 Assemble the Entry Tube 7165 4526 to the ai Entry Portal Handle 7167 4092 by pulling back
10. 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 41 T handle Cat No 7167 4076 Reducer Cat No 7167 4077 Obturator Cat No 7167 4078 Ruler Cat No 7167 4079 Gripper Cat No 7167 4080 Cannulated Impactor Medium Cat No 7167 508 Slotted Hammer Cat No 7167 4082 4 0mm Drill Sleeve Cat No 7167 4083 Screwdriver Release Cat No 7167 4084 Screw Length Sleeve Cat No 7167 4085 Entry Portal Handle Cat No 7167 4092 42 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 43 Catalog information TRIGEN META NAIL Instruments
11. field if magnetic metal is close If it is in the field image disappears Drill Depth Measurement Refer to User Manual Page 16 and 17 for drill depth measurements 28 screw insertion Using the TRIGEN SURESHOT Hexdriver 7169 2809 the screw may be inserted using the Targeter WARNING The standard TRIGEN Hexdrivers are made from magnetic stainless steel that will cause interference with the system and cannot be used Using the Combo Drill Sleeve TRIGEN SURESHOT Inner Drill Sleeve Long Cat No 7169 1165 4 TRIGEN SURESHOT Outer Screw Sleeve Long Cat No 7169 1166 dB While holding the Targeter to bone remove the SURESHOT Inner Drill Sleeve Long 7169 1165 from the SURESHOT Outer Screw Sleeve Long 7169 1166 Use the TRIGEN SURESHOT Hexdriver 7169 2809 to insert the appropriate length screw through the SURESHOT Outer Screw Sleeve Long NO C When screw insertion is complete remove the probe from the IM nail 29 Instruments for standard dynamic and compression locking E Nail Cap Set Screw Cat No 7165 6000 Screw Length Sleeve Cat No 7167 4085 META NAIL Anterior Drop Cat No 7165 4501 Medium Hexdriver Mini Connector Cat No 7163 1066 Cat No 7163 1186 4 0mm Drill Sleeve Universal META NAIL Compression Driver Cat No 7167 4083 Cat No 7165 4528 9 0mm Drill Sleeve Screw Depth Gauge Cat No 7163 1152 Cat No 7163 1189
12. handle The nail is correctly aligned when 1 The line on the insertion barrel matches the line of the nail 2 The A on the nail matches the A on the insertion barrel 3 The apex of the nail s proximal Herzog Bend faces posterior and the drill guide is 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 proximal insertion depth 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 Refer to SURESHOT User Manual for the field accuracy check instructions Surgical procedure after IM Nail Assembly to the Drill Guide Probe selection and assembly Probe connection Assemble the appropriate probe and set the stop for the Connect the probe to either of the probe sensor ports the TRIGEN IM Nail and Drill Guide that will be used on the Trauma Interface CAUTION Proper orientation of the probe to the set stop as shown is required Failure to do so may result in inaccurate targeting TRIGEN SURESHOT META NAIL Semi extended Drill Guide Probe 7169 2803 SURESHOT Probe META Ext connected For META NAIL notches should face anteriorly
13. reserved Trademark of Smith amp Nephew Certain marks Reg US Pat amp TM Off 01361 V1 71181612 REVB 01 14
14. size The appropriate diameter implant will provide translational till within the isthmus of the intramedullary canal Generally selection of a nail approximately 1 1 5mm less than the narrowest canal measurement on the lateral radiograph assists in avoiding implant incarceration during insertion MU IE MN Note The 8 5mm diameter of the Reducer s provides an initial sound for determining canal width in small diameter tibias 25mm E e 35mm yy uo 40mm 45mm U 50mm 55mm et 65mm U Wo 70mm 75mm Vo 80mm 85mm AU U 90mm 95mm ADO i 10 Wi mm 105mm 20 U 110mm 5 0mm Gold Screw Shaft Diameter 25mm 26 cm 30mm 35mm 40mm 45mm 90 50mm 55mm 100 il U 1 il 1 U 1 1 1 i i U U U U 1 1 1 U l ji 1 U 1 U 1 U 1 U 1 U 1 U O 60mm sabem O 4 5mm Grey Screw 20 used w 8 5mm nail only 3lcm 30 32cm 40 33cm 50 34cm mm li S 28cm 29cm w 65mm Size Omm Set Screw Nail Cap Size Omm Nail Cap 35cm 36cm 37cm 38cm 39cm 40cm l 20mm AA Ty 15mm 10mm A 5mm l 4icm 42cm o 43emt 44cm Nail Cap LATERAL VIEW A P VIEW TRIGEN META NAIL Tibial Nail Radiographic Template Cat No 7118 0810
15. the patella to the middle of the patella approximately 1 5 inches in length A second deep incision is made medial to the patella cutting the superior two thirds of the medial retinaculum leaving the cuff intact Extend the incision 1 2 cm into the quadriceps tendon This incision is not midline but through the medial one third of the quadriceps tendon as outlined in the image Sublux the patella laterally and pass the fully assembled entry tube through the skin incision until it is sitting on the tibial plateau Entry portal acquisition Use the femoral condyles as a guide for proper tube placement making sure the Guide Pin Sleeve sits properly as outlined below The entry point is located just medial to the lateral tibial eminence in the AP view and in line with the anterior cortex and intramedullary canal in the lateral view Attach the 3 2mm Tip Threaded Guide Wire 7163 1690 to the drill via the Mini Connector 7163 1186 and insert into the Guide Pin Sleeve Entry portal After definitive guide wire placement remove the Guide Pin Sleeve and carefully slide the Entry Tube down and onto the tibial plateau Attach the 12 5mm Entry Reamer 7163 1116 to power Advance over the guide wire through the Entry Tube to a depth of 4 6cm in the tibia Maintain alignment so as to avoid penetration of the posterior cortex Check position via radiographic imaging and then remove the 12 5mm Entry Reamer and 3 2mm Ti
16. will change color to orange upon successful connection to the Trauma Interface CAUTION 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 CAUTION Connect the Targeter at least 10 minutes prior to targeting in order to ensure proper accuracy Note 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 Note 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 Instruments for opening the proximal tibia 3 2mm Tip Threaded Guide Wire Cat No 7163 1690 12 5mm Entry Reamer Cat No 7163 1116 Entry Portal Handle Cat No 7167 4092 3 2mm T handle Trocar Cat No 7167 4074 Cannulated Awl Cat No 7167 4000 T handle Cat No 7167 4076 Mini Connector Cat No 7163 1186 a Guide Pin Sleeve Cat No 7165 4527 e Ta Entry Tube Cat No 7165 4526 Incision and entry point Lateral subluxation of the patella A midline skin incision is made from the upper pole of
17. 4 amumijjjunm Drill Sleeve Short Cat No 7169 2805 TRIGEN SURESHOT Targeter Cat No 7169 2801 AO Drill Bit Short Cat No 7169 2810 AO Drill Bit Long Cat No 7169 2811 META NAIL Semi Extended Drill Guide Probe Cat No 7169 2803 META Set Stop Cat No 7169 2806 Note When the targeter is out of the preferred range or there is metal or electrical interterence the green and red targeter circles on the Trauma Interface screen mav become unstable and or a warning message will be displaved li the interference is excessive the IM nail image on the Trauma 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 25 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 identifv 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 Ravs necessary Tibia 10 mm 26 Targeting the locking hole With th
18. 6 Cat No Description Qtv 6680 0291 Power Cord 250 Volt 10 Amp Continental Europe 7118 1538 User Manual German 1 TRIGEN SURESHOT Countrv Kit Spain Cat No 7165 7007 Cat No Description Qtv 6680 0291 Power Cord 250 Volt 10 Amp Continental Europe 7118 1539 User Manual Spanish 1 46 TRIGEN SURESHOT Country Kit France Cat No 7165 7008 Cat No Description Qtv 6680 0291 Power Cord 250 Volt 10 Amp Continental Europe 7118 1537 User Manual French 1 TRIGEN SURESHOT Countrv Kit Italv Cat No 7165 7009 Cat No Description Qtv 6680 0291 Power Cord 250 Volt 10 Amp Continental Europe 7118 1536 User Manual Italian 1 TRIGEN SURESHOT Countrv 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 Country Kit South Africa India Cat No 7165 7012 Cat No Description Qtv 6680 0302 Power Cord 250 Volt 10 Amp 1 So Africa India 7118 1540 User Manual English 1 47 For additional information on Blocking Screws and Extraction Techniques please reference the TRIGEN META NAIL Tibial Nail Surgical Technique 7118 1610 Smith amp Nephew Inc 7135 Goodlett Farms Parkway www smith nephew com Cordova TN 38016 USA Telephone 1 901 396 2121 Information 1 800 821 5700 Orders Inquiries 1 800 238 7538 2014 Smith amp Nephew Inc All rights
19. 67 4076 Advance the Reducer into the intramedullarv canal and use the curved tip to direct the 3 0mm Ball Tip Guide Rod past the fracture into the region of the distal epiphvseal scar 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 o pam from the tibial canal Slide the Obturator e 7167 4078 into the back of the T handle during extraction in order to maintain guide rod position within the canal Implant measurement After Reducer removal reconfirm guide rod placement within the distal tibia and slide the Ruler 7167 4079 over the guide rod inside the Entrv Tube to the desired depth The metal tip of the Ruler denotes the driving end of the 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 the Ruler until contact is made with the 3 0mm Ball Tip Guide Rod Implant length is read from the exposed calibrations at the end of the Ruler Sa Note Confirm fracture reduction so as not to underestimate correct implant length Reference the fibula for accurate fracture distraction or compression Note Confirm that the Ruler opens easily Adjust the thumb wheel connection at the end to allow for free movement Template Radiographic templating is used to determine nail
20. 9 7165 5030 7165 5031 7165 5032 7165 5033 7165 5034 Length 24cm 26cm 28cm 29cm 30cm 31cm 32cm 33cm 34cm Contained in the standard implant set 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 5035 7165 5036 7165 5037 7165 5038 7165 5039 7165 5040 7165 5041 7165 5042 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 0mm 5 0mm x 5mm Length 35cm 36cm 3 cm 38cm 39cm 40cm 4lem 42cm 4 5mm 5 0mm 3 Catalog information TRIGEN META NAIL Implants TRIGEN META NAIL 10mm Tibial Set No 7165 3000 Cat No Length Cat No Length 7165 5124 24cm 7165 5135 35cm 7165 5126 26cm 7165 5136 36cm 7165 5128 28cm 7165 5137 37cm 7165 5129 29cm 7165 5138 38cm 7165 5130 30cm 7165 5139 39cm 7165 5131 31cm 7165 5140 40cm 7165 5132 32cm 7165 5141 41cm 7165 5133 33cm 7165 5142 42cm 7165 5134 34cm TRIGEN META NAIL 11 5mm Tibial Set No 7165 3001 Cat No Length Cat No Length 7165 5224 24cm 7165 5235 35cm 7165 5226 26cm 7165 5236 36cm 7165 5228 28cm 7165 5237 37cm 7165 5229 29cm 7165 5238 38cm 7165 5230 30cm 7165 5239 39cm 7165 5231 31cm 7165 5240 40cm 7165 5232 32cm 7165 5241 41cm 7165 5233 33cm 7165 5242 42cm 7165 5234 34cm Contained in the standard implant set 38 TRIGEN M
21. ETA NAIL 13mm Tibial Cat No Length Cat No length 7165 5318 18cm 765 5335 35cm 7165 5320 20cm 765 5336 36cm 7165 5322 22cm 765 5337 37cm 7165 5324 24cm 7165 5338 38cm 7165 5326 26cm 7165 5339 39cm 7165 5328 28cm 765 5340 40cm 7165 5329 29cm 7165 5341 41cm 7165 5330 30cm 765 5342 42cm 7165 5331 31cm 7165 5343 43cm 765 5332 32cm 765 5344 44cm 7165 5333 33cm 7165 5346 46cm 7165 5334 34cm 7165 5348 48cm 7165 5350 50cm Nail Cap Set Screw ste 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 39 Catalog Information TRIGEN META NAIL Instruments TRIGEN META NAIL Blocking Screw Instruments Set No 7165 400 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 Blocking Screw Instrument Case Cat No 7165 4552 Blocking Screw Instrument Lid Cat No 7165 4553 40 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 Entrv Reamer Cat No 7163 1116 Guide Bolt Wrench Cat No 7163 1140 9 0mm Drill Sleeve
22. ated in the original TRIGEN Instrument Set 7163 1326 and the HFN Instrument Set 7170 0001 35 Guide rod jamming technique 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 36 Catalog information TRIGEN META NAIL Implants 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 8 5mm Tibial 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 3002 Cat No 7165 5024 7165 5026 7165 5028 7165 502
23. d the black trigger of the Entry Portal Handle and inserting the Entry Tube into the handle ring Turn the tube until it clicks into a locked position Next place the Guide Pin Sleeve 7165 4527 through the tube until it locks into both the end of the sleeve and Entry Portal Handle ring Note Take time to inspect the Entry Tube as it can become damaged bent or chipped with excessive prior reaming and insertion of other instruments Any flaws in the tube can lead to damage of the surrounding tendons and tissues Warnings and cautions for TRIGEN SURESHOT Refer to the SURESHOT User Manual 7118 1540 for all warnings cautions maintenance cleaning and sterilization instructions Devices for svstem set up Trauma Intertace Cat No 7169 2802 Power Cord Cat No 6680 0193 TRIGEN SURESHOT Targeter Cat No 7169 2801 Note The Targeter will be operated within the sterile field and mav 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 am
24. e 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 Critical Verifv there are no other metal objects including metal triangles in the field Metal interference will cause the svstem to be inaccurate 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 Adjust the trajectorv represented bv 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 Note The green ring must be fullv within the hole of the IM nail displaved on the Trauma Interface screen to ensure accurate drilling 2 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
25. e 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 Refer to the SURESHOT User Manual 7118 1540 for details about the SURESHOT Distal Targeting System ML view 60mm Distal end of nail all knee and distal tibial Top view of nail Non driving end of nail AP view Note These views are not to scale and should be used as a pictorial representation only Material Diameter Lengths Nail color Cross section Proximal diameter driving end Distal 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 Hex Drivers Alternative modes Proximal Locking mW MM mira Specifications 8 5mm TRIGEN META NAIL Tibia TI6AL4V 8 5mm 16 50cm Grey Round 12mm 8 5mm 4 8mm 1 9mm 5 16 24 UNF 4 5mm Grey 4 5mm 4 0mm 25 65mm 4 7mm RT Femoral amp Recon 7 0mm Cannulated Screw PERI LOC Locking Screw No TI6AL4V 10 11
26. h all four proximal screws inserted 4 Omm 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 31 Note Make sure to remove probe before proximal locking Proximal locking Static 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 static 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 Dynamic With the nail countersunk approximately 10mm 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 dynamic slot on the Anterior Drop down to bone Drill both cortices with the 4 0mm Long Pilot Drill Screw measurement and insertion follows the previously described technique Note Use the TIBIA and ALL NAILS holes marked on the META NAIL drop
27. hort 2 7169 2806 META Set Stop 7169 2807 TAN Set Stop 7169 2808 Field Accuracy Gauge 7169 2809 Hexdriver 7169 2816 TAN Anteversion Locking Guide 1 7169 2830 Targeting Instrument Trav 7169 2831 Targeting Instrument Trav Lid 1 pj 7 i Ee a r Pom om o ml illi ir e A CO Comm mo ee ee mm r Other TRIGEN SURESHOT Instruments Cat No Description Qty 7169 1165 Inner Drill Sleeve Long 1 7169 1166 Outer Screw Sleeve Long TRIGEN SURESHOT Targeting Disposables Set Set No 7165 7002 Cat No Description Qtv 7169 2810 AO Drill Bit Short 2 7169 2811 AO Drill Bit Long 1 Additional Disposables Cat No Device 7169 2803 META NAIL Semi Extended Drill Guide Probe used with TRIGEN META NAIL Nail Instrument Set e 7165 4002 45 TRIGEN SURESHOT Country Kit North America Cat No 7165 7003 Cat No Description Qtv 6680 0193 Power Cord 125 Volt 10 Amp North 1 America Hospital Grade 7118 1540 User Manual English 1 Additional countrv kits TRIGEN SURESHOT Countrv Kit Australia Cat No 7165 7004 Cat No Description Qtv 6680 0303 Power Cord 250 Volt 10 Amp Australia NZ 7118 1540 User Manual English 1 TRIGEN SURESHOT Countrv Kit Continental Europe Cat No 7165 7005 Cat No Description Qtv 6680 0291 Power Cord 250 Volt 10 Amp Continental Europe 7118 1540 User Manual English 1 TRIGEN SURESHOT Country Kit Germany Cat No 7165 700
28. implant tab located in the lower left corner of the navigation screen 21 Surgical procedure after IM Nail Assembly to the Drill Guide Drill sleeve attachment Tightly secure the selected drill sleeve to the Targeter Note The short long and long combo drill sleeves 7169 2805 7169 2804 and 7169 1166 can be loosened from the Targeter using the slot in the TRIGEN Hammer 7167 4082 22 Nail insertion Remove Entry Tube and Handle 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 intramedullarv canal mav be indicated if excessive force is required to insert the nail Verify fracture reduction as the nail crosses the fracture site bv paving close attention to rotation length alignment distraction and or shortening Check final nail position in both the AP and lateral views for correct alignment Tip Provisional fixation of the proximal tibial fragments mav be obtained bv reattaching the Anterior Drop and by inserting the gold 9 0mm Drill Sleeve 7163 1152 and silver 4 0mm Drill Sleeve 7167 4083 into one of the two Blocking Screw holes in the Drop and passing a 4 0mm Long Pilot Drill 7163 1110 4 0mm Long Pilot Drill 7163 1110 is interchangeable with 4 0mm AO L
29. n the same manner Thread the Cannulated Impactor Medium 7167 5081 or Cannulated Impactor Long 7163 1185 into the back of the Disposable Nail Extractor 7163 1320 and then thread the assembly into the top of the nail Remove the remaining proximal 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 distal locking screws and all but one of the proximal locking screws as previously described Under fluoroscopy insert a 3 2mm Tip Threaded Guide Wire 7163 1690 into the top of the nail on power or by hand Make a 2cm incision around the pin and advance the 12 5mm Entry Reamer over the pin and into the top 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 top of the nail Remove the remaining proximal 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 loc
30. ong Drill 7163 1121 23 Check nail depth Proximal In the lateral view confirm nail position by observing the notch present at the nail drill guide junction If compression or dynamic locking is desired it is recommended to countersink the nail approximately 10mm to avoid implant prominence Distal In the AP and lateral views confirm that the nail has been inserted to the desired depth Distal third tibial fractures require at least three locking screws to maintain stability so optimal insertion depth is essential 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 Tip For additional confirmation of the proximal location of the nail take the 3 2mm Guide Pin and place under the base of the drill guide where the drop would be connected and press to skin The base of the drill guide and end of the nail are in line With the Guide Pin in position take a lateral radiograph This will give you a good idea of the location 24 Items to target and drill distal holes d 74 smith amp nephew TRIGEN SURESHOT Distal Targeting System e e Trauma Interface Cat No 7169 2802 Power Cord Cat No 6680 0193 Inner Drill Sleeve Long Cat No 7169 1165 Outer Screw Sleeve Long Cat No 7169 1166 Drill Sleeve Long Cat No 7169 280
31. p 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 WARNING The maximum temperature of the Targeter body can reach 47 Celsius at ambient room temperatures above 30 C The Targeter body should not remain in constant contact with a patient s exposed skin for more than one minute Surgical procedure OR preparation 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 CAUTION No other electrical devices should be placed near the Trauma Interface See the Guidance and Manufacturer s Declaration Separation Distances table at the end of this document Note If the Trauma Interface does not power on make sure the switch is in the on position Note The means for mains disconnection of power to the Trauma Interface is the appliance inlet located below the power switch The Trauma Interface should not be positioned such that it is difficult to reach this location TRIGEN SURESHOT Targeter connection When the displav prompts for tool connections connect the TRIGEN SURESHOT Targeter 7169 2801 to the Targeter port on the Trauma Interface SURESHOT Probe SURESHOT Targator maf found rex found Surgical procedure OR preparation The SURESHOT Targeter
32. p Threaded Guide Wire Alternative technique Entry portal With the Entry Tube and Entry Portal Handle still in the joint space attach the T handle 7167 4076 to the Cannulated Awl 7167 4000 and insert into the proximal tibia to a depth of 4 6cm 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 T handle the cannulation Cat No 7167 4076 Entry Portal Handle Cat No 7167 4092 3 2mm T handle Trocar ji Cat No 7167 4074 Entrv Tube Cat No 7165 4526 Cannulated Awl Cat No 7167 4000 Instruments for fracture reduction and reaming Z Y Entrv Tube Cat No 7165 4526 Entrv Portal Handle Cat No 7167 4092 Ruler Cat No 7167 4079 T handle Cat No 7167 4076 Gripper Cat No 7167 4080 Reamer Heads Cat No 7111 8231 8246 3 0mm x 1000mm Ball Tip Guide Rod Cat No 7163 1626 Obturator Cat No 7167 4078 Flexible Reamer Shaft Cat No 7111 8200 Reducer Cat No 7167 4077 13 Fracture reduction Insert the back end of the 3 0mm Ball Tip Guide 7163 1626 into the front of the Gripper 7167 4080 and gentiv close the trigger grip Connect 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 71
33. proximal tibia Clin Orthop Relat Res 1996 Number 328 pp 185 189 Indications The TRIGEN META NAIL Tibial Nail is indicated for fractures of the proximal and distal third of the tibia including the shaft stable and unstable factures nonunions malunions and for the prophylactic nailing of impending pathological factures Note This technique deals with the joint space around the knee Caution must be taken at all times during the procedure The Entry Tube is needed for guide pin placement reaming measuring fracture reduction and insertion of the guide rod Please be aware there is a possibility of damaging the posterior aspect of the patella and the surrounding tendons if care is not taken The TRIGEN META NAIL Semi extended Instrument Set has been designed with these concerns in mind 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
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