S2 Tibial Nail. Operative Technique

Transcription

1 S2 Tibial Nail Operative Technique

2 Introduction Contributing Surgeons : Dr. George Anastopoulos, Dept. of Orthopaedics and Traumatology General Hospital G. Gennimatas Athens, Greece Prof. Kwok Sui Leung, M.D. Dept. of Orthopaedics and Traumatology Chinese University of Hong Kong Prince of Wales Hospital, Hong Kong 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 University of Texas - Southwestern Medical Center Dallas, Texas USA Dr. Gilbert Taglang, Chief Surgeon - Emergency Department Center of Traumatology and Orthopaedics, CTO - Strasbourg, France This publication sets forth detailed recommended 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 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. Distal Targeting Device Calibration 4.8. Nail Insertion 4.9. Distal Guided Locking Mode (via Distal Targeting Device) Proximal Guided Locking Mode (via Target Device) Freehand Distal Locking End Cap Insertion Nail Removal Ordering Information - Implants Ordering Information - Instruments 20 22

4 Introduction 1. Introduction 1.1. Implant Features The S2 Nailing System represents the latest and most comprehensive development of the original intra-medullary 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 offers the following competitive advantages: Accommodates reamed or unreamed procedures. Provides solutions for very proximal and very distal tibia fractures Distal Guided Locking option (via Distal Targeting Device) Through the development of a common, streamlined and intuitive surgical approach, both in principle and in detail, the S2 Tibial Nail offers significantly increased speed and functionality for the treatment of fractures as well as simplifying the training requirements for all personnel involved. The S2 Tibial Nail is the realization of superior biomechanical intramedullary stabilization using small caliber, strong, cannulated implants for internal fixation of the tibia. The S2 Tibial Nail may be used for very proximal and very distal fractures due to the two M/L proximal holes for static locking and 3 distal (M/L, A/P, M/L) locking holes. The distal most hole is centered at 5mm from the tip of the nail to better address hard to reach distal fractures. Common 5mm cortical screws simplify the surgical procedure and promote a minimally invasive approach. Fully Threaded Locking Screws are available for regular locking procedures. The 8mm S2 Tibial Nail can only be locked distally with 4mm Fully Threaded Screws. As with all diameters of the S2 Tibial Nails, 5mm Fully Threaded Screws are used for proximal Locking. End Caps are available in various sizes to provide a best fit for every indication and prevent bony or soft tissue ingrowth into the proximal threads of the nail. The End Cap will also tighten down on the most proximal locking Screw, thus avoiding lateral sliding of the nail. All the S2 Tibial Nail implants are made of Stainless Steel (316LVM). The S2 Tibial Nails are cannulated, not slotted and have a fluted profile for an optimal bending stiffness. In addition, two longitudinal grooves (one on each side of the nail), between the 2 M/L Distal Locking Holes, are designed for the Distal Guided Locking Mode technique (via S2 Distal Targeting Device). The main principle of this technique is based on easy nail detection with a Probe inserted into this groove. The groove is used to further guide the Probe into the Locking Hole. For detailed information about Distal Guided Locking Mode technique, please refer to the S2 Distal Targeting Device OP Technique, REF. NO. B See the detailed chart on the next page for design specifications and size offering.

5 Features S2 Tibial Nail Diameter 8 14mm Sizes mm (in 15mm increments) 19mm 35mm 10 Herzog Bend (at 50mm from driving end) S2 Locking Screws mm Fully Threaded Locking Screws L = mm 4.0mm Fully Threaded Locking Screws for 8mm Nails (Distal Holes only) L = 25 60mm Screw length is measured from the top of the head to the tip 4 Distal Bend (at 60mm from the tip) 25mm 15mm 5mm S2 End Caps Standard +5mm +10mm +15mm

6 Features 1.2. Instrument Features 1.3. References The major advantage of the instrument system is a break-through 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 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 number and color coded to indicate the step during the surgical procedure in which the instrument is used. Unique to the S2 Nailing System is a special Distal Targeting Device designed for Distal Guided Locking Technique. The S2 Distal Targeting Device offers the competitive advantage of: Minimizing fluoroscopy time Helping to avoid misdrilling Reducing the operative time. For detailed information about the Distal Targeting Device please refer to the S2 Distal Targeting Device Operative Technique, REF. NO. B 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: 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: 4.2mm = Green For mm Fully Threaded Locking Screws. 4.0mm = Orange For 4,0mm Fully Threaded Locking Screws for the distal holes, only for the 8mm Tibial Nail.

7 Stryker Trauma GmbH Prof.-Küntscher Str Schönkirchen Germany Cat.-No.: /Rev.:00 Indications 2. Indications The S2 Tibial Nail is indicated for: Open or closed shaft fractures with a very proximal and/or very distal extent in which locking screw fixation can be obtained Multi-fragment fractures Segmental fractures Pathologic and impending pathologic fractures Tumor resections Corrective osteotomies/mal-unions Non-unions Comminuted fractures with or without bone loss 3. Pre-operative Planning An X-Ray Template, Tibia ( ) is available for pre-operative planning (Fig. 1). End caps S2 Tibial Nail Scale: 1,10 : 1 10 % Magnification Thorough evaluation of pre-operative radiographs of the affected extremity is critical. Careful radiographic examination can prevent intraoperative complications. +15mm +10mm +5 mm Ø 11,5mm Ø 12mm Ø 13mm Ø 14mm Ø 8 mm L Ø 9 mm 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. Check with local representative regarding availability of nail sizes. 240mm 255mm 270mm 285mm 300mm Ø 10 mm Ø 11 mm Ø 12 mm Ø 13 mm Ø 14 mm Nail diameters Ø8mm Ø9mm Ø10mm Ø11mm Ø12mm Ø13mm Nail length range for all diameters : mm Locking Options S2 Tibial Nail Static Ø14mm 315mm 330mm 345mm 360mm 375mm 390mm 405mm 420mm Fig. 1

8 Operative Technique 4. Operative Technique 4.1. Patient Positioning and Fracture Reduction 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 accommodate 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 potential 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) Entry Point 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 immediately 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 285mm K-Wire ( S), the Ø12mm Rigid Reamer ( ) is used to access the medullary canal (Fig. 5). Fig. 2 Alternatively, to penetrate the cortex, the Ø10mm Straight ( ) or Curved ( ) Awl may be used (Fig. 6). During opening of the entry portal with the Awl, dense cortex may block the tip of the Awl. An Awl Plug ( ) can be inserted through the Awl to avoid penetration of bone debris into the cannulation of the Awl shaft. 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. M L Fig. 3 Fig. 4 Fig. 5 Fig. 6

9 Operative Technique 4.4. Unreamed Technique If an unreamed technique is preferred, the 3 800mm 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 in place. Fig Reamed Technique For reamed techniques, the 3 800mm Ball Tip Guide Wire ( S) is inserted through the fracture site. Except for the 8mm Tibial Nails, use of the Ball Tip Guide Wire does not require a Guide Wire exchange. The Universal Rod ( ) with Reduction Spoon ( ) may be used as a fracture reduction tool to facilitate Guide Wire insertion through the fracture site (Fig. 8). Reaming (Fig. 9) is commenced in 0.5mm increments until cortical contact is appreciated. Final reaming should be 1.5 2mm larger than the diameter of the nail to be used. The proximal diameter of the 8 11mm diameter nails is 11.5mm. Additional proximal metaphyseal reaming may be required to facilitate nail insertion. Nail sizes 12 14mm have a constant diameter. 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. The Ball Tip at the end of the Guide Wire will stop the Bixcut reamer head (Fig.10). * See pages for additional Bixcut Reamer system details. Fig. 8 Fig. 9 Fig. 10

10 Operative Technique 4.6. Nail Selection Diameter The diameter of the selected nail should be 1.5 2mm smaller than that of the last reamer used. nail diameters M/L Holes Hole Position Proximal Length The X-Ray Ruler, Tibia ( ) 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 positions (Fig. 11). Hole Position Distal A/P Hole M/L Holes nail length 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 & 1000mm Guide Wires with markings for the Tibia and Femur. End of Guide Wire Ruler Confirm the position of Guide Wire tip before measurement. Upon completion of reaming, the appropriate size nail is ready for insertion. Fig. 12 End of Guide Wire Ruler equals Measurement Reference 4.7. Distal Targeting Device Calibration Calibration of the S2 Distal Targeting Device must be performed prior to nail insertion, if decided to be used for Distal Guided Locking procedure. For detailed information about Calibration technique, please refer to the Operative Technique for S2 Distal Targeting Device (REF. NO: B ). 10 Fig. 13

11 Operative Technique 4.8. Nail insertion The selected nail is assembled on the Nail Adapter ( ) with the Nail Holding Screw ( )(Fig. 14). Securely tighten the Nail Holding Screw with the Universal Joint Socket Wrench ( ) so that it does not loosen during nail insertion (Fig.15). If Calibration of the S2 Distal Targeting Device was performed before Nail Insertion, the nail is already assembled on the Nail Adapter. Prior to insertion: 1. Recheck that the Nail is tightly secured to the Nail Adapter. 2. Verify the correct position of the nail relative to the Nail Adapter: during insertion, the convexity of the Herzog bend must be placed posterior, with the Nail Adapter on the medial side of the tibia. 3. Check correct alignment by inserting a Drill bit through the assembled Tissue Protection- and Drill Sleeve placed in the required holes of the Targeting Device. 4. The 8mm Tibial Nails require exchanging the Ø3 800mm Ball Tip Guide Wire ( S) for the Ø3 800mm Smooth-Tip Guide Wire ( S) prior to nail insertion. Use the Teflon Tube ( S) to facilitate the Guide Wire exchange. 5. S2 Tibial nails with diameters 9 14mm do not require a Guide Wire exchange. The Strike Plate ( ) is threaded into the Nail Adapter next to the Nail Holding Screw or directly into the Nail Holding Screw to avoid any unintended bending moment during nail insertion. The Nail is inserted by hand over the Ø3 800mm Guide Wire (if used) and into the entry site of the proximal tibia (Fig. 16). 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 create an anterior tract in the proximal fragment. 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. 14 Fig. 15 Fig

12 Operative Technique 4.8. Nail insertion (continued) The Slotted Hammer can be used on the Strike Plate (Fig. 17) if dense bone is encountered. Alternatively, the Universal Rod ( ) may be attached to the Strike Plate and used in conjunction with the Slotted Hammer ( ) to insert the nail (Fig. 18). A captured Sliding Hammer ( ) is available as an optional addition to the basic instrument set. When locking the S2 Tibial Nail, the nail is countersunk a minimum of 2mm to the cortex surface. The final nail depth should be well below the cortex surface to minimize irritation of the Patellar Tendon. Fig. 17 If the S2 Distal Targeting Device will be used for Distal Guided Locking, the nail must be countersunk at least 12 mm. The final insertion depth is reached after pulling back the nail 10mm, in a later step. Please refer to the S2 Distal Targeting Device - Operative Technique (REF. NO: B ) for detailed information. 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 Hammer may then be attached to the Strike Plate to carefully and smoothly retract the assembly. DO NOT hit on the Target Device (Fig. 18). 2mm 12mm Static Static with Guided Distal Locking Fig. 18 Fig. 19 Attach the Targeting Adapter ( ) to the Nail Adapter and lock it with the Fixation Screw ( ). Remove the Guide Wire prior to drilling holes and inserting the Locking Screws. A chamfer is located on the proximal end of the nail to help identify the junction of the nail and insertion post under fluoroscopy. Three circumferential grooves are located on the insertion post of the Target Device Assembly at 2mm, 10 mm and 15 mm from the proximal end of the nail. Depth of insertion may be visualized with the aid of fluoroscopy (Fig. 19). Additionally, a 3 285mm K-Wire may be inserted through the Target Device to identify the junction of the nail and insertion post (Fig. 20). 12 Fig. 20

13 Operative Technique 4.9. Distal Guided Locking Mode (Via Distal Targeting Device) If the S2 Distal Targeting Device is going to be used, Distal Guided Locking should always be performed before Proximal Locking! This is because the Distal Guided Locking technique requires free movement of the nail in the medullary canal. For detailed information about the Distal Guided Locking procedure, please refer to the S2 Distal Targeting Device - Operative Technique (REF. NO: B ). 1 Nail Adapter 3 Fixation Screw A The 8mm Tibia Nail cannot be locked distally in a Guided Mode (via Distal Targeting Device). This is because 4mm Fully Threaded Screws must be used for distal locking of the 8mm Tibia Nail, while the Guided Locking procedure is only suitable for the 5mm Locking Screws Proximal Guided Locking Mode (Via Target Device) Before locking the nail proximally, confirm that the Nail Holding Screw is securely tightened by using the Universal Socket Wrench. Also check that the Fixation Screw ( ) is firmly tightened by hand to ensure that the Targeting Adapter is fixed on the Nail Adapter. 2 Targeting Adapter 4 Target Template Fig. 21 The Target Template can be placed into the Targeting Adapter in one direction only. The arrow on the Targeting Adapter has to line up with the arrow on the Target Template (Fig. 21). The Target Template will block all locking holes in the Targeting Adapter that cannot be used with the S2 Tibia Nail (Fig. 22). Do not use the Target Device without Target Template! Both proximal M/L Locking Screws must be used for locking of the S2 Tibial Nail. Never tighten the Fixation Screw ( 3 ) in the groove ( A ) of the Nail Adapter (Fig. 21)! In this position, the Fixation Screw cannot secure the Targeting Adapter on the Nail Adapter. The Target Device with the Target Template ( ) placed into the Targeting Adapter ( ) is designed to provide the 2 M/L proximal locking options for the S2 Tibial Nail. Fig

14 Operative Technique Proximal Guided Locking Mode (continued) The Tissue Protection Sleeve, Long ( ) together with the Drill Sleeve, Long ( ) and the Trocar, Long ( ) are positioned through the most distal static hole of the Target Template by pressing the Safety Clip. 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 (Fig.23). locked free Safety Clip To release the Tissue Protection Sleeve, the Safety Clip must be pressed again and held while removing the sleeve. Fig. 23 A small skin incision is made, and the assembly is pushed through until the Tissue Protection Sleeve is in contact with the medial cortex of the tibia (Fig. 24). The Trocar is removed, with the Tissue Protection Sleeve and Drill Sleeve remaining in position. For accurate drilling and easy determination of screw length, use the center tipped, calibrated Ø Drill ( S). The Drill is forwarded through the Drill Sleeve and pushed onto the cortex. Fig. 24 After drilling both cortices, the screw length may be read directly off the calibrated Drill at the end of the Drill Sleeve (Fig. 25). If measurement with the Screw Gauge, Long ( ) is preferred, first remove the Drill Sleeve and read the screw length directly at the end of the Tissue Protection Sleeve. 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 3mm beyond the far cortex, the end of the screw will also be 3mm beyond. Fig mm 14

15 Operative Technique 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 3mm beyond the far cortex (Fig. 26). 50mm Alternatively, stop the drill when it engages the far cortex and measure the drill bit depth off of the calibrated drill. Add 5mm to this length to obtain the correct screw length. Fig. 26 When the Drill Sleeve is removed, the correct 5mm Locking Screw is inserted through the Tissue Protection Sleeve using the Screwdriver Shaft, Long ( ) with Teardrop Handle (702429) (Fig. 27). Fig. 27 The screw is advanced through both cortices. The screw is near its proper seating position when the groove around the shaft of the screwdriver is approaching the end of the Tissue Protection Sleeve (Fig. 28). Fig. 28 Repeat the locking procedure for the more proximal M/L Locking Screw (Fig. 29). Fig

16 Operative Technique Freehand Distal 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. The center-tipped Ø Drill ( S) or optional Ø 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. Fig. 30 Fig

17 Operative Technique After drilling both cortices the screw length may be read directly off the calibrated Short Screw Scale ( ) at the green ring on the centertipped Drill (Fig. 32). Alternatively, the Screw Gauge (1806-0) for Freehand technique can be used insted of the Screw Scale, Short to determine the screw length. Green Ring 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, mm ( ) and Teardrop Handle (Fig. 34). The Screwdriver Shaft, Long may be used in conjunction with the optional Long Screw Capture Sleeve ( ). 20mm Fig. 32 Distal locking should always be performed with at least two screws, locking the hole nearest the fracture site first. The distal hole configuration follows: M/L (most proximal), A/P and M/L (most distal). Fig. 33 8mm Tibial Nails must always be locked distally with 4.0mm Fully Threaded Screws. For the 8mm Tibial Nails, the Ø Drill ( S) is used to drill both corticies prior to inserting the 4mm Fully Threaded Locking Screws in the distal holes. As with all sizes of the S2 Tbial Nail, the 8mm Nails use mm Screws proximally. Fig

18 Operative Technique End Cap Insertion After removal of the Target Device, an End Cap is used. Four different sizes of End Caps are available to adjust nail length and to reduce the potential for bony ingrowth into the proximal threads of the nail (Fig. 35). Standard +5mm +10mm +15mm Fig. 35 The End Cap is inserted with the Screwdriver Shaft, Long ( ) and Teardrop Handle (702429) after intra-operative radiographs show satisfactory reduction and hardware implantation (Fig. 36 & 37). Fully seat the End Cap to minimize the potential for loosening. The End Cap will tighten down on the most proximal screw and prevent M/L movement of the nail. The wound is closed in the usual manner. Fig. 36 Fig

19 Operative Technique Nail removal Nail removal is an elective procedure. If needed, the End Cap is removed with the Screwdriver Shaft and Teardrop Handle (Fig. 38). 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. 39). The Screwdriver Shaft may be used in conjunction with the optional Screw Capture Sleeve ( ). The Slotted Hammer or optional Sliding Hammer is used to extract the nail in a controlled manner(fig. 40). Fig. 38 Close the wound in the usual manner. Fig. 39 Fig

20 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 StSt Diameter Length REF mm mm S2 Tibial Nail S2 Tibial Nail Ordering Information - Implants StSt Diameter Length REF mm mm * Implants are packed sterile. 20

21 Ordering Information - Implants 5mm Fully Threaded Locking Screws StSt Diameter Length REF mm mm 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 mm Fully Threaded Locking Screws StSt Diameter Length REF mm mm S S S S S S S S End Caps StSt Diameter Length REF mm mm S S S S 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 REF. Number. 21

22 Ordering Information - Instruments REF Description S2 Tibia Standard Instruments X-Ray Ruler, Tibia Guide Wire Ruler Awl, Curved, Ø10mm K-Wire 3 285mm (outside of U.S.) Guide Wire Handle Guide Wire Handle Chuck Universal Rod Reduction Spoon Wrench 8mm/10mm Strike Plate S2 Nail Holding Screw (2 each) Slotted Hammer Tissue Protection Sleeve, Long Drill Sleeve, Long Screwdriver Shaft AO, Long Screw Driver Shaft, mm Trocar, Long Screw Gauge, Long Long Screw Gauge (20mm 80mm) Socket Wrench, Universal Joint 10mm Drill Ø mm, AO, (outside of U.S.) Drill Ø mm, AO, (outside of U.S.) Teardrop Handle, AO coupling Rigid Reamer, Ø12mm Target Template Sleeve Fixation Screw Target Device, S2 (3 components) S2 Nail Adapter S2 Targeting Adapter Fixation Screw Dedicated Instrument Box, S2 * 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 Description Optional Instruments S S S S S S S S S X-Ray Template, Tibia Awl, Straight, Ø10mm Awl Plug K-Wire 3 285mm, sterile (U.S.) Insertion Wrench, 10mm Guide Wire, Ball Tip, 3 800mm (outside of U.S.) Guide Wire, Ball Tip, 3 800mm, sterile (U.S.) Guide Wire, Smooth Tip, 3 800mm (outside of U.S. for 8mm Tibia) Guide Wire, Smooth Tip, 3 800mm, sterile (U.S for 8mm Tibia.) Sliding Hammer Screwdriver, Long Screw Capture Sleeve, Long Ratchet T-Handle AO Awl, Curved, 90 Handle Extraction Rod, Conical, Ø8mm Drill Ø mm AO, sterile (U.S.for 8mm Tibia) Drill Ø mm, AO, (outside of the U.S. for 8mm Tibia) Drill Ø mm, AO, sterile (U.S.) Drill Ø mm, AO, sterile (U.S.) Drill Ø mm, AO, (outside of U.S.) Drill Ø mm, AO, sterile (U.S.) Drill Ø 230mm, AO, sterile (U.S.) Drill Ø 230mm, AO, (outside of U.S.) Screw Scale, Short Teflon Tube, (outside of U.S. for 8mm Tibia) Teflon Tube, sterile ( U.S. for 8mm Tibia) Special Order Items Screwdriver, Extra Short Extraction Adapter T-Handle, AO Coupling Rigid Reamer, Ø11.5mm Awl, Straight Ø11.5mm Reaming Protector Long Freehand Tissue Protection Sleeve Long Drill Sleeve Ø4.2mm * 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 Bixcut 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 8mm shaft diameters significantly reduce IM pressure. Typical Standard Reamer Ø14mm Clearance area : 32% of cross section Bixcut Reamer Ø14mm Clearance area : 59% of cross section Recent studies 1 have demonstrated that the pressures developed within the medullary cavity through the introduction of unreamed IMnails 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. Bixcut 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 Mehdi 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 Bixcut Modular Head Bixcut Shaft AO fitting REF Description Diameter mm REF Description Length mm Bixcut Shaft Modified Trinkle fitting (sterile) REF Description Length mm (S) (S) Shaft, AO Shaft, AO Shaft, Mod. Trinkle 450 Shaft, Mod. Trinkle Bixcut Fixed Head AO fitting REF Diameter Length mm mm Bixcut Fixed Head Modified Trinkle fitting + REF Diameter Length mm mm * 6.5* 7.0* * 6.5* 7.0* Bixcut Trays + Use with Stryker Power Equipment REF Description Tray, Modular Head (up to size 22.0mm) Tray, Modular Head (up to size 2mm) Tray, Fixed Head (up to size 1mm) * Use with 2.2mm 800mm Smooth Tip and 2.5mm 800mm Ball Tip Guide wires only. Federal law (U.S.A) restricts this device to sale by or on the order of a licensed physician. 25

26 Notes 26

27 Notes 27

28 Trauma, Extremities & Deformities Biologics Surgical Products Neuro & ENT Stryker Trauma GmbH Prof.-Küntscher-Strasse 1-5 D Schönkirchen Germany The information presented in this brochure is intended to demonstrate a Stryker product. Always refer to the package insert, product label and/or user instructions before using any Stryker product. Surgeons must always rely on their own clinical judgment when deciding which products and techniques to use with their patients. Products may not be available in all markets. Product availability is subject to the regulatory or medical practices that govern individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area. Stryker Corporation or its subsidiary owns the registered trademark: Stryker Stryker Corporation or its subsidiary owns, uses or has applied for the following trademarks: S2, Bixcut Literature Number : B LOT D0807 Copyright 2007 Stryker