TIBIAL NAIL Tx OPERATIVE TECHNIQUE

Transcription

1 TM TIBIAL NAIL Tx OPERATIVE TECHNIQUE

2 TM TIBIAL NAIL Tx Contributing Surgeons: David Seligson, M.D. Professor and Vice Chairman of the Department of Orthopaedic Surgery University of Louisville Louisville, Kentucky, USA Adam Starr, M.D. Assistant Professor Department of Orthopedic Surgery Univ. of Texas - Southwestern Medical Center Dallas, Texas, USA Ivan F. Rubel, M.D. Assistant Professor of Orthopedics Director of Orthopedics at Kings County Hospital Chief of Fracture Service at SUNY Downstate Medical Center Brooklyn, NY, USA This publication sets forth detailed recoended procedures for using Stryker Trauma devices and instruments. It offers guidance that you should heed, but, as with any such technical guide, each surgeon must consider the particular needs of each patient and make appropriate adjustments when and as required. A workshop training is required prior to first surgery. 2

3 TABLE OF CONTENTS 1. Introduction 1.1. Implant Features 1.2. Instrument Features 1.3. References 2. Indications 3. Pre-operative Planning 4. Operative Technique 4.1. Patient Positioning and Fracture Reduction 4.2. Incision 4.3. Entry Point 4.4. Unreamed Technique 4.5. Reamed Technique 4.6. Nail Selection 4.7. Nail Insertion 4.8. Guided Locking Mode (via Target Device) 4.9. Freehand Distal Locking End Cap Insertion Nail Removal 5. Blocking Screw Technique (optional) Ordering Information - Implants Ordering Information - Instruments

4 INTRODUCTION 1. INTRODUCTION The S2 Nailing System represents the latest and most comprehensive development of the original intramedullary principles presented by Prof. Gerhard Küntscher in Stryker Trauma has created a new generation locking nail system, bringing together all the capabilities and benefits of separate nailing systems to create a single, integrated surgical resource for fixation of long bone fractures (1). The S2 Tibial Nail Tx offers the competitive advantages of: Α highly stable implant due to the special proximal locking configuration. Accoodating reamed or unreamed procedures. Providing solutions for very proximal and very distal tibia fractures. Through the development of a coon, streamlined and intuitive surgical approach, both in principle and in detail, the S2 Tibial Nail Tx offers significantly increased speed and functionality for the treatment of fractures as well as simplifying the training requirements for all personnel involved IMPLANT FEATURES The S2 Tibial Nail Tx is the realization of superior biomechanical intramedullary stabilization using small caliber, strong cannulated implants for internal fixation of the Tibia. The S2 Tibial Nail Tx may be used for very proximal and very distal fractures featuring two oblique and one M/L proximal holes for static locking and 3 distal (M/L, A/P, M/L) locking holes. Note: The most distal hole is centered at 5 from the tip of the nail to better address hard to reach distal fractures. Coon 5 cortical screws simplify the surgical procedure and promote a minimally invasive approach. Fully Threaded Locking Screws are available for regular locking procedures. Important: The 8 S2 Tibial Nail Tx can only be locked distally with 4 Fully Threaded Screws. As with all diameters of the S2 Tibial Nail Tx, 5 Fully Threaded Screws are used for proximal Locking. An End Cap is available to prevent bony or soft tissue ingrowth into the proximal threads of the nail. All implants of the S2 Tibia Tx Nailing System are made of Stainless Steel (316LVM). The S2 Tibial Nails Tx are cannulated, not slotted and have a fluted profile for an optimal bending stiffness. See the detailed chart on the next page for design specifications and size offering. 4

5 IMPLANT FEATURES S2 Tibial Nail Tx Diameter Sizes ( in 15 increments) S2 Locking Screws Fully Threaded Locking Screws L = Herzog Bend (at 50 from driving end) 4.0 Fully Threaded Locking Screws for 8 Nails (Distal Holes only) L = Note: Screw length is measured from the top of the head to the tip 6 Distal Bend (at 60 from the tip) S2 Tx End Cap 5 only one size Standard 5

6 INSTRUMENT FE ATURES 1.2. INSTRUMENT FEATURES The major advantage of the instrument system is a breakthrough in the integration of the instrument platform which can be used not only for the complete S2 Nailing System, but will be the platform for all future Stryker Trauma nailing systems, reducing complexity and inventory. The instrument platform offers advanced precision and usability and features ergonomically styled targeting devices. In addition to the advanced precision and usability, the instruments are color and number coded to indicate the step during the surgical procedure in which the instrument is used REFERENCES 1. M.E. Müller, et al., Manual of Internal Fixation, Springer Verlag, Berlin. 2. M.L.M.J. Goessens, R. Sijbers, J.S. Harbers, J.W.J.L. Stapert, Application of a proximal entry point for intramedullary nailing of the tibia, Osteosinthese International (2001) 9: William M. Ricci, Michael O Boyle, Joseph Borrelli, Carlo Bellabarba and Roy Sanders, Fractures of the Proximal Third of the Tibial Shaft treated with Intramedullary Nails and Blocking screws, Jurnal of Orthopaedic Trauma, Vol. 15, No. 4, pp , 2001 Step Color Number Opening Red 1 Reduction Brown 2 Nail Introduction Green 3 Guided Locking Light Blue 4 Freehand Locking Dark Blue 5 Drills Drills feature color coded rings: 4.2 = Green For Fully Threaded Locking Screws. 3.5 = Orange For 4.0 Fully Threaded Locking Screws for the distal holes, only for the 8 Tibial Nail, Tx. 6

7 INDICATIONS 2. INDICATIONS The S2 Tibial Nail Tx is indicated for: Open and/or closed tibial shaft fractures with a very proximal and/or very distal extent in which locking screw fixation can be obtained Multi-fragment fractures Segmental fractures Corrective osteotomies Mal-unions Non-unions Pathologic and impending pathologic fractures Tumor resections Pseudarthrosis 3. PRE-OPERATIVE PLANNING An X-Ray Template, Tibia Tx ( ) is available for pre-operative planning (Fig. 1). Thorough evaluation of pre-operative radiographs of the affected extremity is critical. Careful radiographic examination can prevent intra-operative complications. For standard mid-shaft fractures, the proper nail length should extend from just below the Tibial Plateau at the appropriate mediolateral position to just proximal to the Epiphyseal Scar of the ankle joint. Note: Check with local representative regarding availability of nail sizes. Fig. 1 7

8 OPER ATIVE TECHNIQUE 4.1. PATIENT POSITIONING AND FRACTURE REDUCTION Fig. 2 a) The patient is placed in the supine position on a radiolucent fracture table and the leg is hyperflexed on the table with the aid of a leg holder, or b) The leg is free-draped and hung over the edge of the table (Fig. 2). The knee is flexed to >90. A triangle may be used under the knee to accoodate flexion intra-operatively. It is important that the knee rest is placed under the posterior aspect of the lower thigh in order to reduce the opportunity of vascular compression and the risk of pushing the proximal fragment of the tibia forward. Anatomical reduction can be achieved by internal or external rotation of the fracture and by traction, adduction or abduction, and must be confirmed under image intensification. Draping must leave the knee and the distal end of the leg exposed INCISION A para-tendenous incision is made from the patella extending down approximately 1.5-4cm in preparation of nail insertion. The Patellar Tendon may be retracted laterally or split at the junction of the medial third, and lateral two-thirds of the Patellar Ligament. This exposes the entry point (Fig. 3). L M 4.3. ENTRY POINT Fig. 3 Fig. 4 Fig. 5 Fig. 6 Fig. 3 Based on radiological image, the medullary canal is opened through a superolateral plateau entry portal (2). The center point of the portal is located slightly medial to the lateral tibial spine as visualized on the A/P radiograph and iediately adjacent and anterior to the anterior articular margin as visualized on the true lateral radiograph. Radiographic confirmation of this area is essential to prevent damage to the intra-articular structure during portal placement and nail insertion (Fig. 4). The opening should be directed with a central orientation in relation to the medullary canal. After penetrating the cortex with the 3 x 285 K-Wire ( S), the Ø12 Rigid Reamer ( ) is used to access the medullary canal (Fig. 5). Alternatively, the Ø10 Awl, Straight ( ) may be used to penetrate the cortex (Fig. 6). Note: A more distal entry point may result in damage to the posterior cortex during nail insertion. Note: Guiding the Rigid Reamer over the K-Wire prior to K- Wire insertion within the Proximal Tibia will help to keep it straight while guiding the opening instrument centrally towards the canal. Do not use bent K-Wires. 8

9 OPER ATIVE TECHNIQUE 4.4. UNREAMED TECHNIQUE If an unreamed technique is preferred, the 3 x 800 Smooth Tip Guide Wire ( S) is passed through the fracture site using the Guide Wire Handle ( and ) (Fig. 7). Internal rotation during insertion will aid in passing the Guide Wire down the tibial shaft. The Guide Wire should lie in the center of the metaphysis and the diaphysis in both the A/P and M/L views to avoid offset positioning of the nail. The Guide Wire Handle is removed leaving the Guide Wire 4.5. REAMED TECHNIQUE For reamed techniques, the 3 x 800 Ball Tip Guide Wire ( S) is inserted through the fracture site. Except for the 8 Tibial Nails, use of the Ball Tip Guide Wire does not require a Guide Wire exchange. The Universal Rod with Reduction Spoon or Reduction Tip may be used as a fracture reduction tool to facilitate Guide Wire insertion through the fracture site (Fig. 8). Fig. 7 Note: The Ball Tip at the end of the Guide Wire will stop the Bixcut reamer head (Fig.10). Reaming (Fig. 9) is coenced in 0.5 increments until cortical contact is appreciated. Final reaming should be larger than the diameter of the nail to be used. Note: The proximal diameter of the 8-11 diameter nails is Additional proximal metaphyseal reaming may be required to facilitate nail insertion. Nail sizes have a constant diameter. Fig. 10 Bixcut Reamer* The complete range of Bixcut reamers is available with either modular or fixed heads. The optimized cutting flute geometry is designed to reduce intramedullary pressure and temperature. This is achieved by the forward and side cutting face combination of the reamer blades. The large clearance rate resulting from the reduced number of reamer blades, coupled with the reduced length of the reamer head, relieves the intramedullary pressure and provides efficient removal of reamed material. *See pages for additional Bixcut Reamer system details. Fig. 8 Fig. 9 9

10 OPER ATIVE TECHNIQUE Hole Position Distal Fig. 11 A/P Hole nail diameters M/L Holes nail length M/L Holes Oblique Holes Hole Position Proximal 4.6. NAIL SELECTION Diameter The diameter of the selected nail should be smaller than that of the last reamer used. Length The Tibia X-Ray Ruler, Tibia Tx ( ) may be used to determine nail diameter and length. The X-Ray Ruler may also be used as a guide to help determine final Locking Screw position (Fig. 11). Alternatively, nail length may be determined by measuring the remaining length of the Guide Wire. The Guide Wire Ruler ( ) is placed on the Guide Wire and the correct nail length is read at the end of the Guide Wire on the Guide Wire Ruler (Fig. 12 & 13). The Guide Wire Ruler is calibrated for 800 & 1000 Guide Wires with markings for the Tibia and Femur. End of Guide Wire Ruler Upon completion of reaming, the appropriate size nail is ready for insertion. Fig. 12 Fig. 13 End of Guide Wire Ruler equals Measurement Reference 10

11 OPER ATIVE TECHNIQUE 4.7. NAIL INSERTION The selected nail is assembled onto the Tibial Target Device ( ) with the Tibial Nail Holding Screw ( ) (Fig. 14). Securely tighten the Nail Holding Screw with the Insertion Wrench ( ) so that it does not loosen during nail insertion. To attach the Nail Handle to the Targeting Arm, turn the Quick-Lock Ring of the Targeting Arm clockwise. Triangles on the Quick-Lock Ring and the Targeting Arm indicate the correct position to attach the Nail Handle when both triangles are in line with each other. Note: Prior to insertion 1. Recheck that the Nail is tightly secured to the Nail Handle. 2. Verify the correct position of the nail relative to the Nail Handle as indicated on the insertion post. 3. A drill bit may be inserted through the targeting device and through the nail holes to help check alignment and hole configuration. 4. The 8 Tibial Nails require exchanging the 3 x 800 Ball Tip Guide Wire ( S) for the 3 x 800 Smooth-Tip Guide Wire ( S) prior to insertion. Use the Teflon Tube ( S) to facilitate the Guide Wire exchange. The Strike Plate ( ) is threaded into the Nail Handle next to the Nail Holding Screw or directly into the Nail Holding Screw to avoid any unintentional bending moment during nail insertion. The Nail is inserted by hand over the 3 x 800 Ball Tip Guide Wire (if used) and into the entry site of the proximal tibia (Fig. 15). Gently manipulate the nail to help avoid penetration of the posterior cortex. If the nail is deflected towards the posterior cortex, remove the nail, and hyperflex the knee. Under image control, use a straight reamer to ream an anterior tract in the proximal fragment. Quick Lock Strike Plate Nail Holding Screw Nail Handle Targeting Arm Fig. 14 The Nail is advanced through the entry point past the fracture site to the appropriate level. Remove the Guide Wire once the nail is past the fracture site. Fig

12 OPER ATIVE TECHNIQUE 4.7. NAIL INSERTION (CONTINUED) The Slotted Haer ( ) can be used on the Strike Plate (Fig. 16) or if dense bone is encountered. Alternatively, the Universal Rod ( ) may be attached to the Strike Plate and used in conjunction with the Slotted Haer to insert the nail (Fig. 17). A captured Sliding Haer ( ) is available as an optional addition to the standard instrument set. Fig. 16 The three circumferential grooves on the insertion post act as a guide while inserting the nail to the correct depth (Fig. 19). The correct depth position for the S2 Tibial Nail Tx may be determined with the first proximal groove of the Nail Adapter Fig. 19 When locking the Tibial Nail, Tx, the nail is countersunk a minimum of 2 to the chondral surface. The final nail depth should be well below the chondral surface to minimize irritation of the Patellar Tendon. Fig. 17 Repositioning of the nail should be carried out either by hand or by using the Strike Plate attached to the Target Device. The Universal Rod ( ) and Slotted Haer may then be attached to the Strike Plate to carefully and smoothly retract the assembly. DO NOT hit on the Target Device. Technical Tip: A chamfer is located on the proximal end of the nail to help identify the junction of the nail and insertion post under fluoroscopy. The three circumferential grooves on the insertion post are located at 2, 7 and 12 from the proximal end of the nail and help determine depth of insertion Attach the Targeting Arm by rotating the spring loaded Quick-Lock Ring on the Target Arm clockwise while connecting it to the knob on the end of the Nail Handle (Fig. 18). Fig. 18 Note: Remove the Guide Wire prior to drilling holes and insert the Locking Screws. 12

13 OPER ATIVE TECHNIQUE 4.8. GUIDED LOCKING MODE (VIA TARGET DEVICE) Before locking the nail proximally, confirm that the Nail Holding Screw is securely tightened by using the Universal Joint Socket Wrench, and check that the Targeting Arm is properly attached to the Nail Handle. 1 Nail Handle The Target Device was designed to work with the T2 Tibial Nails. Therefore, it features more locking options than needed for the S2 Tibial Nail Tx (Fig 20). Note: DO NOT USE THE DYNAMIC HOLE of the Target Device. There is no corresponding hole in the S2 Tibial Nail Tx. 2 Targeting Arm Fig. 20 For T2 Tibial Nails only! Important: For the Guided Locking of the S2 Tibial Nail Tx, use the 3 Static holes ONLY (Fig. 21) 3 The Tissue Protection Sleeve, Long ( ) together with the Drill Sleeve, Long ( ) and the Short Trocar, Long ( ) is inserted into the Target Device by pressing the Safety Clip (Fig. 22). The Friction Locking mechanism will keep the sleeve in place and prevent it from falling out. It will also prevent the sleeve from sliding during screw measurement. 1 2 Fig. 21 To release the Tissue Protection Sleeve, the Safety Clip must be pressed again and held while removing the sleeve (Fig. 22). Safety Clip released locked Fig

14 OPER ATIVE TECHNIQUE 4.8. GUIDED LOCKING MODE (CONTINUED) For locking of the S2 Tibial Nail Tx, both proximal Oblique Locking Screws and the M/L Locking Screw may be used. In higly unstable coinuted fractures, this locking configuration improves stability of the proximal fragment. Always start with the most distal oblique Fully Threaded Locking Screw. The Tissue Protection Sleeve, Long (assembled with the Drill Sleeve, Long and the Trocar, Long) is positioned through the hole on the Target Device. A small skin incision is made and, while pressing the Safety Clip, the Tissue Protection Sleeve is pushed through until it is in contact with the anterior cortex (Fig. 23). Fig. 23 The Trocar is removed, with the Tissue Protection Sleeve and Drill Sleeve remaining in position. Fig For accurate drilling and easy determination of screw length use the center tipped, calibrated Ø4.2x340 Drill ( S). The centered Drill is forwarded through the Drill Sleeve and pushed onto the cortex. After drilling both cortices, the screw length may be read directly off of the calibrated Drill at the end of the Drill Sleeve. If measurement with the Screw Gauge, Long ( ) is preferred, first remove the Drill Sleeve, Long and read the screw length directly at the end of the Tissue Protection Sleeve, Long (Fig. 24). Note: The position of the end of the Drill as it relates to the far cortex is equal to where the end of the screw will be. Therefore, if the end of the Drill is 3 beyond the far cortex, the end of the screw will also be 3 beyond. Important: The Screw Gauge is calibrated so that with the bend at the end pulled back flush with the far cortex, the screw tip will end 3 beyond the far cortex (Fig. 25). Alternatively, stop the drill when it engages the far cortex and measure the drill bit depth off of the calibrated drill. Add 5 to this length to obtain the correct screw length. Fig

15 OPER ATIVE TECHNIQUE When the Drill Sleeve is removed, the correct Locking Screw is inserted through the Tissue Protection Sleeve using the Screwdriver Shaft, Long ( ) (Fig. 26). Fig. 26 The screw is advanced through both cortices. The screw is near its proper seating position when the groove around the shaft of the screwdriver approaches the end of the Tissue Protection Sleeve (Fig. 27). Fig. 27 Repeat the locking procedure for the more proximal oblique and the M/L Locking Screws (Fig. 28). Fig

16 OPER ATIVE TECHNIQUE 4.9. FREEHAND LOCKING The freehand technique is used to insert Locking Screws into both the M/L and A/P holes in the nail. Rotational alignment must be checked prior to locking the nail statically. Multiple locking techniques and radiolucent drill devices are available for freehand locking. The critical step with any freehand locking technique is to visualize a perfectly round locking hole with the C-Arm. Fig. 30 Fig. 31 The center-tipped Ø4.2x130 Drill ( S) is held at an oblique angle pointing to the center of the locking hole (Fig. 30 and Fig. 31). Upon X-Ray verification, the Drill is placed perpendicular to the nail and drilled through the medial cortex. Confirm in both the A/P and M/L planes by X-Ray that the drill passes through the hole in the nail. Green Ring After drilling both cortices the screw length may be read directly off the calibrated Short Screw Scale ( ) at the green ring on the center-tipped Drill (Fig. 32). As detailed in the proximal locking section, the position of the end of the drill is equal to the end of the screw as they relate to the far cortex (Fig. 33). Routine Locking Screw insertion is employed with the assembled Screwdriver Shaft, Long or Screwdriver Shaft, 3.5x85 ( ) and Teardrop Handle (Fig. 34). Fig. 32 Fig Fig. 33 Fig. 34 Note: The Screwdriver Shaft, Long may be used in conjunction with the optional Screw Capture Sleeve, Long ( ). Note: Distal locking should always be performed with at least two screws, locking the hole nearest the fracture site first. Always lock the most proximal M/L hole. The distal hole configuration follows: M/L (most proximal), A/P and M/L (most distal). Note: 8 Tibial Nails must always be locked distally with 4 Fully Threaded Screws. For the 8 Tibial Nails, the Ø3.5x130 Drill ( S) is used to drill both cortices prior to inserting the 4 Fully Threaded Locking Screws in the distal holes. Important: As with all sizes of the S2 Tbial Nail, the 8 Nails use Screws proximally. 16

17 OPER ATIVE TECHNIQUE END CAP INSERTION After removal of the Target Device, the S2 End Cap Tx (Fig. 34) is used to reduce the potential for bony ingrowth into the proximal threads of the nail (Fig. 34). Fig. 34 The End Cap is inserted with the Screwdriver Shaft and Teardrop Handle after intra-operative radiographs show satisfactory reduction and hardware implantation (Fig. 35 & 36). Fully seat the End Cap to minimize the potential for loosening. The wound is closed in the usual manner. Fig. 35 Fig

18 OPER ATIVE TECHNIQUE NAIL REMOVAL Nail removal is an elective procedure. If needed, the End Cap is removed with the Screwdriver Shaft and Teardrop Handle (Fig. 37). The Universal Rod is inserted into the driving end of the nail. All Locking Screws are removed with the Screwdriver Shaft and Teardrop Handle (Fig. 38). Note: The Screwdriver Shaft may be used in conjunction with the optional Screw Capture Sleeve ( ). Fig. 37 The Slotted Haer or optional Sliding Haer is used to extract the nail in a controlled manner(fig. 39). Close the wound in the usual manner. Fig. 38 Fig

19 BLOCK ING SCRE W (OPTIONAL ) 5. BLOCKING SCREW In extremely proximal tibial fractures, the Nail often sits against the posterior cortex which may cause anterior angulation of the fracture because the shaft position is fixed by the nail (Fig. 40). The principle of the use of a Blocking Screw (3) is to prevent posterior nail passage by decreasing the effective diameter of the canal and directing the nail more anterior as shown (Fig. 41). With the Blocking Screw in place, the nail may align the shaft (fracture) more accurately (Fig. 42) Note: An A/P Blocking Screw may be used to correct varus - valgus positioning, based on the same principle. Fig. 40 Blocking Screw Placed to Prevent Nail passage Fig. 41 Radiographic location of Superolateral Nail Entry Portal Just medial to lateral spine Anterior adjacent to joint Superolateral Entry Portal Fig

20 20 ORDERING INFORMATION - IMPL ANTS S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S *Implants are packed sterile. REF Diameter Length S2 TIBIAL NAIL, Tx REF Diameter Length S2 TIBIAL NAIL, Tx

21 ORDERING INFORMATION - IMPL ANTS 5 FULLY THREADED LOCKING SCREWS 4 FULLY THREADED LOCKING SCREWS REF Diameter Length REF Diameter Length S S S S S S S S S S S S S S S S S S S S S S S S S S S S END CAPS REF Diameter Length S Ø Standard Note: Outside of the U.S., Locking Screws and other specific products may be ordered non-sterile without the S at the end of the corresponding Cat. Number. 21

22 ORDERING INFORMATION - INSTRUMENTS REF Description S2 Tibial Nail Tx - Standard Instruments S2 Combined Instrument Set (U.S.) X-Ray Ruler, Tibia, Tx Guide Wire Ruler Awl, Curved, Ø Awl, Straight, Ø K-Wire 3 x 285 (outside of U.S.) Guide Wire Handle Guide Wire Handle Chuck Universal Rod Reduction Spoon Wrench 8/ Insertion Wrench Strike Plate Nail Holding Screw, Tibia (2 of each) Slotted Haer Tissue Protection Sleeve, Long Drill Sleeve, Long Screwdriver Shaft AO, Long Screw Driver Shaft, 3.5 x Trocar, Long Screw Gauge, Long Extraction Rod, Conical, Ø Screw Scale, Short Socket Wrench, Universal Joint Drill Ø4.2x340, AO, (outside of U.S.) Drill Ø4.2x130, AO, (outside of U.S.) Drill Øx230, AO, (outside of U.S.) Teardrop Handle, AO coupling Screwdriver, Long Rigid Reamer, Ø Target Device, Tibia (2 components) Combined Instrument Tray, S2 (5 items) Opening/Insertion Universal Insert Locking Insert, long sleeves S2 Targeting Insert Metal Base Box Lid Stryker IM Instruments *Outside of the U.S, instruments with an "S" may be ordered non-sterile without the "S" at the end of the corresponding REF.NO. 22

23 ORDERING INFORMATION - INSTRUMENTS REF Optional Instruments Description S S S S S S S X-Ray Template, Tibia, Tx K-Wire 3 x 285, sterile (U.S.) Guide Wire, Ball Tip, 3 x 800 (outside of U.S.) Guide Wire, Ball Tip, 3 x 800, sterile (U.S.) Guide Wire, Smooth Tip, 3 x 800 (outside of U.S. for 8 Tibia) Guide Wire, Smooth Tip, 3 x 800, sterile (U.S for 8 Tibia.) Sliding Haer Screw Capture Sleeve, Long Ratchet T-Handle AO Drill Ø3.5x130 AO, (outside of the U.S. for 8 Tibia) Drill Ø3.5x130 AO, sterile (U.S. for 8 Tibia) Drill Ø4.2x340, AO, sterile (U.S.) Drill Ø4.2x130, AO, sterile (U.S.) Long Screw Gauge (20-80) Teflon Tube, sterile Awl, Curved, 90 Handle Special Order Items: Screwdriver, Extra Short Extraction Adapter T-Handle, AO Coupling Rigid Reamer, Ø11.5 Awl, Straight Ø11.5 Reaming Protector Long Freehand Tissue Protection Sleeve Long Drill Sleeve Ø 4.2 *Outside of the U.S, instruments with an "S" may be ordered non-sterile without the "S" at the end of the corresponding REF.NO. 23

24 ORDERING INFORMATION - INSTRUMENTS TM Complete range of modular and fixed-head reamers to match surgeon preference and optimize O.R. efficiency, presented in fully sterilizable cases. Large clearance rate resulting from reduced number of reamer blades coupled with reduced length of reamer head to give effective relief of pressure and efficient removal of material. Cutting flute geometry optimized to lower pressure generation. Forward- and side-cutting face combination produces efficient material removal and rapid clearance. Double-wound shaft transmits torque effectively and with high reliability. Low-friction surface finish aids rapid debris clearance. Smaller, 6 and 8 shaft diameters significantly reduce IM pressure. Typical Standard Reamer Ø14 Clearance area: 32% of cross section TM Reamer Ø14 Clearance area : 59% of cross section Recent studies 1 have demonstrated that the pressures developed within the medullary cavity through the introduction of unreamed IM nails can be far greater than those developed during reaming but this depends very much upon the design of the reamer. After a three year development study 2 involving several universities, the factors that determine the pressures and temperatures developed during reaming were clearly established. These factors were applied to the development of advanced reamers that demonstrate significantly better performance than the best of previous designs. 1 Jan Paul M. Frolke, et al.; Intramedullary Pressure in Reamed Femoral Nailing with Two Different Reamer Designs. Eur. J. of Trauma, 2001 #5 2 Medhi Mousavi, et al.; Pressure Changes During Reaming with Different Parameters and Reamer Designs, Clinical Orthopaedics and Related Research Number 373, pp ,

25 ORDERING INFORMATION - INSTRUMENTS REF Description Diameter Bixcut Modular Head REF Diameter Bixcut Fixed Head - AO fitting Length Bixcut Shaft - AO fitting (S) (S) Bixcut Trays REF Description Length Shaft, AO Shaft, AO REF Description Length Bixcut Shaft - Modified Trinkle fitting (sterile) REF Shaft, Mod. Trinkle Shaft, Mod. Trinkle + Description Tray, Modular Head (up to size 22.0) Tray, Modular Head (up to size 26.0) Tray, Fixed Head (up to size 1) REF *6.0 *6.5 * Bixcut Fixed Head - Modified Trinkle fitting Diameter *6.0 *6.5 * Length * Use with 2.2 x 800 Smooth Tip and 2.5 x 800 Ball Tip Guide wires only. + Use with Stryker Power Equipment 2003 Stryker Corporation. All rights reserved. Printed in Germany. Stryker and Howmedica logos are registered trademarks of the Stryker Corporation. To ensure the best quality of its products and their improvements Stryker reserves the right to modify all or part of their products. Caution: Federal law (U.S.A) restricts this device to sale by or on the order of a licensed physician. 25

26 26

27 27

28 TM TM FEMUR A / R The S2 Femoral A/R Nailing System is one of the first femoral nailing systems to offer an option for either an antegrade or a retrograde approach to repair fractures of the femur. One Implant for Left and Right side and Two Approaches (antegrade and retrograde) with the same implant, and the option of Distal Guided Locking with a special Distal Targeting Device. TM FEMUR COMPRESSION Stryker Trauma has created a new generation locking nail system, that brings together the benefits and capabilities of past nailing systems to create a single, integrated surgical resource for the fixation of femoral fractures. The S2 Femoral Nail, Compression combines static, dynamic and apposition/compression locking mode options and provides the option of Distal Guided Locking with a special Distal Targeting Device. TM TIBIA COMPRESSION The S2 Tibial Nailing System represents the latest and most comprehensive development of the original intramedullary principles presented by Prof. Gerhard Küncher in The main advantages include different locking options from static to dynamic and apposition/ compression. The system features a coon, streamlined instrumentation system and the option of Distal Guided Locking with a special Distal Targeting Device. The Trochanteric Gaa Locking Nail and the Long Gaa Locking Nail, have been designed by surgeons. Combining the strength and biomechanical advantages of the existing Gaa family they are the Golden standard for proximal femoral fractures with more than treatments world-wide. I.M. SAW (Not available in the U.S.) The I.M. Saw is suitable for closed osteotomies of the femur and tibia in all cases which allow the use of intramedullary nails for fragment fixation. Closed osteotomies with subsequent fragment fixation are indicated for correction of rotational deformities, angular deformities along the axis, and lengthening and shortening procedures. TM REAMING SYSTEM After a three year study involving several universities, the factors that determine the pressures and temperatures developed during reaming were clearly established. These factors were then applied to the development of advanced reamers that demonstrate significantly better performance than the best of previous designs. MANUFACTURER: Stryker Trauma GmbH Prof.-Küntscher-Strasse 1-5 D Schönkirchen Germany REF NO. B LOT A3303 Stryker Corporation. All rights reserved.