Biomet Vision Pin-To-Bar Fixation System. Surgical Technique

Transcription

1 Biomet Vision Pin-To-Bar Fixation System Surgical Technique

2 Contents Introduction... Page 1 Indications and Contraindications... Page 2 Basic Principles And Biomechanical Concepts...Page 3 Instruments... Page 6 System Tray... Page 9 Bone Screw Insertion Technique... Page 10 Surgical Technique... Page 14 Ordering Information... Page 22 Sterilization... Page 27 Further Information... Page 28 B

3 Introduction The Biomet Vision Pin-To-Bar Fixation System allows independent pin placement. With this system, simple and effective external fixation can be applied. The Biomet Vision System is versatile enough to be used as both temporary and definitive fixation. Temporizing measures include spanning transarticular fixation or non-spanning fixation for severe soft tissue damage or contamination. Definitive fixation uses include unilateral single bone fixation, hybrid configuration and even use in hinge designs at the elbow and knee. It can also be applied to open book pelvic injuries as a resuscitive frame or a definitive fixator. The simplicity and ease of use make this fixator friendly in the operating room for quick applications. For delayed open reconstruction in periarticular fractures, the Biomet Vision Pin-To-Bar Fixation System functions as an excellent means of portable traction. This allows the patients the benefit of soft tissue healing while having the option of being at home and waiting for their elective procedures. It allows the surgeon the benefits of getting the patient out of the hospital quickly and readmitting for a well-planned surgery or for transfer to the appropriate physician. Spanning fixator placement can easily be converted to a hybrid configuration by simply adding a ring with tensioned wires to the articular fragment. This assembly then connects to the previously placed pins and rods. Adaptation to the hybrid or ankle frame can also be preformed with the included components. NOTE: Picture shown is for demonstration purposes only. This example would require perfect reduction. 1

4 Indication and Contraindications INDICATIONS The DynaFix Vision Unilateral System and the DynaFix Vision External Fixation System are external fixation device intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality. CONTRAINDICATIONS Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions. Additional indications for the Biomet Vision FootRing System, a sub system of the DynaFix Vision External Fixation System include: Correction of deformity Revision procedures where other treatments or devices have been unsuccessful Bone reconstruction procedures Fusions and replantations of the foot Charcot reconstruction and Lisfranc dislocations Ankle distraction (arthrodiastasis) 2

5 Basic Principles And Biomechanical Concepts Half-Pin Frame Biomechanics The ideal frame stiffness is unknown. To increase frame stability, the following principles should be followed: 1. Use the largest diameter pin possible without the pin being larger than 1/3 the diameter of the bone. 6. For osteopenic bone increase the number of pins in the construct. 7. Maximize the pin spread within a fixed 5-Hole Clamp or 3-Hole Clamp. 2. Maximize pin spread within each fracture fragment. 3. Place the Rod as close to the skin as possible, making sure to leave enough room for additional soft tissue swelling. 4. Placing pins out of plane will add stiffness in additional planes. 5. Place a second Rod on the frame (double stacked). DFS Bone Screws Component And Instrument Review SLM Rapid Rod-To-Rod Clamp Description SLM Rapid Rod-To-Rod Clamp The SLM Rapid Rod-To-Rod Clamp has a serrated locking mechanism, which can be tightened from either side of the clamp with a 5.0 mm Allen Wrench. (Please note the directional arrow for locking etched on the clamp surface) The clamp was designed for rapid application and secure attachment to the Biomet Vision Rods. The key feature of the SLM Rapid Rod-To- Rod Clamp is the ability to secure the clamp from both sides in a single step locking procedure. These clamps are MRI safe. Biomet Vision Clamps Description Hole Clamp Hole Clamp The 3 and 5-Hole Clamps were designed for multi-pin fixation, which increases frame stiffness. The Clamp Cover Bolts are locked down with the 5.0 mm Allen Wrench to secure Bone Screws within the clamp. The 2 Clamp 3/5 Post can be attached to both sides of the clamp for Rod or Bone Screw attachment. The 2 Clamp 3/5 Post is secured to the 3 or 5-Hole Clamps with the Ratcheting T-Handle (P/N and P/N 03122). NOTE: These clamps are not recommended for spanning fixators. SLM Rapid 4.0mm-6.0 mm Screw-To-Rod Clamp Description SLM Rapid 4.0 mm-6.0 mm Screw Clamp 3 Hole Clamp (P/N 03121) 5 Hole Clamp (P/N 03122) The SLM Screw-To-Rod Clamp was designed for ease of use and rapid locking. A single step serrated lock allows for speed of application and secure purchase on rods, 4.0 mm, 5.0 mm, 6.0 mm bone screws and 4.0 mm, 5.0 mm, 6.0 mm Transfixing Screw. This clamp is locked with a 5.0 mm Allen Wrench (PN 03110). The key feature of the SLM Screw-To-Rod Clamp is the ability to snap on to both the rod and the shank of 4.0 mm, 5.0 mm, 6.0 mm screws and Transfixing Screws. This clamp also has the ability to lock to the shank of 4.0 mm, 5.0 mm, 6.0 mm diameter screws. These clamps are MRI safe. 2 Clamp 3/5 Post Description Clamp 3/5 Post The 2 Clamp 3/5 Post is utilized with the 3-Hole and 5-Hole Clamps primarily for Rod attachment, but can also be used for Bone Screw Clamp attachment. The 2 Clamp 3/5 Post is secured to either the 3-Hole Clamp or the 5-Hole Clamp with a 5.0 mm Allen Wrench or 9.0 mm Wrench. 3

6 Component And Instrument Review (Continued) Transfixing Screws Description mm Screw mm Screw mm Screw Bent U-Bars Description Bent U-Bar (190 mm Inner Dia.) Bent U-Bar (220 mm Inner Dia.) Bent U-Bar (250 mm Inner Dia.) The 4.0 mm, 5.0 mm and 6.0 mm Transfixing Screws were designed primarily for temporizing fixation techniques which typically span a joint and zone of injury. The Transfixing Screws are secured to the frame with either style Rapid Bone Screw Clamp. All sizes of Transfixing Screws are equipped with a drilling tip and centrally threaded body. The 6.0 mm Transfixing Screw is unique in that it has a removable drill tip. It is important to note that the 6.0 mm Transfixing Screw should not be reversed while the removable drill tip is attached or it may become detached while in bone or soft tissue! The Bent U-Bars are used primarily for periarticular fracture fixation with bone screws. The bars have an angled step off to allow for enhanced radiographic visualization and surgical access. Please note that these bars were not designed for small tensioned wire fixation and only Screw Clamps or Rod-To-Rod Clamps should be utilized with the Bent U-Bars. TIP: The removal of the 6.0 mm drill tip may be accomplished by using two T-Handle Screw Inserters at each end. NOTE: 6.0 mm Transfixing Screw cannot be used with Triple Stack. 4

7 Biomet Vision Rods Triple Stack Aluminum Description mm x 9.5 mm (Dia.) mm x 9.5 mm (Dia.) mm x 9.5 mm (Dia.) mm x 9.5 mm (Dia.) mm x 9.5 mm (Dia.) mm x 9.5 mm (Dia.) Carbon Description mm x 9.5 mm (Dia.) mm x 9.5 mm (Dia.) mm x 9.5 mm (Dia.) mm x 9.5 mm (Dia.) mm x 9.5 mm (Dia.) mm x 9.5 mm (Dia.) mm x 9.5 mm (Dia.) mm x 9.5 mm (Dia.) The Biomet Vision Rods are available in aluminum and carbon. These materials vary in stiffness with carbon being the stiffer of the two and can be utilized to make a construct more or less rigid. These Rods are offered in a 9.5 mm diameter, and are available in a variety of lengths. Carbon fiber Rods have the added benefit of being radiolucent and extremely lightweight. The Triple Stack (TS) trocar should not be used to protect soft tissue during drilling and screw insertion. The TS is designed to help minimize soft tissue damage while adding to the effectiveness of screw insertion. The TS contains a friction fit between the soft tissue and the drill sleeve. The TS allows the two components to remain engaged after the trocar has been used to dimple the bone and then been removed. Once the trocar is withdrawn, the bone can be drilled and the drill guide can be withdrawn. This will allow the screw to be inserted through the soft tissue into the bone. The serrated teeth on the soft tissue sleeve will maintain its position to the drill hole. The TS can be used free hand or through the Biomet Vision 3 or 5 Hole Clamp. The Triple Stack will provide: 1. Minimal soft tissue damage. 2. Simple dimpling of the bone. 3. Retention of the drill hole site after removal of the drill sleeve. 5

8 Instruments 5.0 mm Quick Wrench P/N: mm Allen Wrenches P/N: (Top Image) Low Profile (Bottom Image) C/D Wrench P/N: mm Hex Square Shaft, Short P/N: C/D Strut (30mm) P/N: TS 3.2 mm Drill Sleeves P/N: (60 mm) (100 mm) TS Soft Tissue Sleeves P/N: (60 mm) (100 mm) (125 mm) TS 4.8 mm Drill Sleeves P/N: (60 mm) (100 mm) (125 mm) 6

9 TS Trocars (For 4.8 mm Drill Sleeves) P/N: (60 mm) (100 mm) (125 mm) Bone Screw Drivers P/N: (4.0 mm) (6.0 mm) Bone Screw Inserter (Square Drive) P/N: mm Hex Shaft, Long P/N: TS Trocars (For 3.2 mm Drill Sleeves) P/N: (60 mm) (100 mm) Biomet Vision Pin-To-Bar Fixation System Tray (Empty) P/N:

10 Instruments (Continued) Disposables Drill Bits P/N: (3.2 mm x 240 mm) (4.8 mm x 240 mm) Tip designed to stabilize drill bit on bone to prevent wandering. DFS Bone Screws (Assorted Diameters/Lengths) 8

11 System Tray Complete System Tray - P/N: Lower Tier Middle Tier Pin Caddy Upper Tier 9

12 Bone Screw Insertion Technique 1. Pre-operative planning is recommended prior to application of this device. Access potential screw site location based on fracture pattern, involved bone and associated safe soft tissue corridor. 1 Prep and drape in routine sterile fashion. 2. Obtaining a preliminary reduction of the fracture site may make bone screw location easier to identify, but is not necessary for pin insertion. The first bone screw is generally inserted in to the shortest or most difficult fragment. When possible, allow 2-1/2 cm of distance between fracture site and first bone screw. Figure 1 3. A cm incision is made and blunt dissection to the bone. 4. A triple-stack consisting of an appropriate size/length trocar, soft tissue guide and drill guide is then utilized to identify the center of the bone and establish the correct orientation of the screw tract to be pre-drilled. The orientation of the insertion of the bone screw should usually be perpendicular to the axis of the bone to maximize biomechanical stability. (Figure 1). 1 Behren, F. And Searls, K.: JBJS (Br) 68: ,

13 5. Once the screw site is selected use gentle pressure to maintain contact between the soft tissue guide and the cortex of the bone. Extract the Trocar. (Figure 2). 6.0 mm Screw Shank Diameter Drill Guide/Drill Bit Screw 4.8 mm 6.0 mm/5.0 mm Cortical 3.2 mm 6.0 mm/5.0 mm Cancellous 3.2 mm 4.5 mm/3.5 mm Cortical 2.9 mm 3.5 mm/3.2 mm Cortical 4.0 mm Screw Shank Diameter Drill Guide/Drill Bit 2.7mm 2.0mm Screw 3.3 mm/3.0 mm Cortical 3.0 mm/2.5 mm Cortical Figure 2 NOTE: Bone screw diameter should not exceed 1/3 diameter of the bone. 6. Insert matching drill bit into drill guide. Drill both cortexes. (Figure 3). NOTES: 1. Once you have inserted a tapered bone screw you will lose purchase if you back it out. Figure 3 2. Self-drilling, self-tapping screws are available for those who wish to use them. 11

14 Bone Screw Insertion Technique (Continued) 7. Drilling should be done bicortically with care not to penetrate into underlying soft tissue. (Figure 4). 8. After bicortical penetration of the drill bit, the drill bit and drill guide are withdrawn. (Figure 5 and 6). Maintain contact and position of the soft tissue. Figure 4 Figure 5 Figure 6 12

15 9. The appropriate length screw is then inserted through the soft tissue sleeve. (Figure 7). The bone screw T-Wrench is used to advance the screw into the bone (Figure 8). To obtain optimal purchase, all bone screws must be bicortical with no less than 2.0 mm protruding from the far cortex and about 5.0 mm remaining outside the near cortex. Remove Soft Tissue Sleeve. (Figure 9). Since screw is tapered, far cortex cannot be accurately judged by feel, therefore image intensification is utilized to confirm depth of penetration. Figure 7 Figure 8 Figure 9 13

16 Surgical Technique* Pelvis Fractures Unstable pelvic ring injuries Open-book pelvic fractures Highly contaminated wounds Patients who cannot physiologically tolerate an extended surgical procedure Supplementing posterior fixation Anterior Superior Iliac Spine (ASIS) Two pins are applied to either iliac crest and connected with an anterior frame. The Anterior Superior Iliac Spine (ASIS) is identified and the insertion points are 2.0 cm posterior for the first pin. The second pin is inserted approximately cm posterior to the first along the crest. A small incision is centered over the iliac crest/tubercle and sharply dissected down to bone. The medial and lateral bit borders of the crest are identified. The 4.8 mm drill bit and drill Biomet Vision Pelvis Iliac Crest (Anterior View) * 5.0 mm Quick Wrenches (P/N 14630) can be used for provisional hand-tightening of the bone screw clamps. Reduction and final tightening can be achieved using the 5.0 mm Allen Wrenches. guide are then used to drill the cortex in the middle to a depth of approximately 1.0 cm. The 6.0 mm pin is then inserted through the soft tissue sleeve. Care must be taken to ensure that the pin does not penetrate the inner or outer table of the crest. The second pin is inserted in a similar fashion. Screw clamps are used to connect the two half-pins on either side. The frame is trapezoidal in shape and fixed such that the patient can sit up in bed. Surgeons are encouraged to achieve reduction by applying a compressive force across the pelvic ring by pushing against the greater trochanter. It is not recommended to push against the screw clamps. This will increase forces on the pin to bone interface. This can also increase or exacerbate posterior instability. Pushing from the greater trochanter will provide an even compressive force across the pelvic ring. Once adequate compression has been achieved, all locking components should be definitively tightened. Traction is applied as may be necessary. 14

17 Anterior Inferior Iliac Spine (AIIS) AIIS is identified as single pin fixation for quick pelvic stabilization. One pin is inserted into each anterior inferior iliac spine (AIIS). These obviously, are deeper pins, and an image intensifier is required. A pin size of at least 200 mm is recommended. Pin insertion technique should follow standard protocol for manual pin insertion. Care must be taken to avoid the hip joint. Supra-acetabular pin placement, less familiar to most surgeons than iliac wing pin placement is, can provide a more reliable pin-bone interface and thus allow improved reduction ability with fewer soft-tissue complications. Because of their location, supra-acetabular pins also seem to be better tolerated than iliac crest pins when used for definitive management of the pelvic ring disruption. Anterior Inferior Iliac Spine (Anterior View) Anterior Inferior Iliac Spine (Lateral View) 15

18 Surgical Technique (Continued) Midshaft Femur Fracture Pediatric femur fractures Vascular injury with prolonged ischemia time Severe soft tissue compromise Half-pins are usually inserted from the lateral side of the femur. Ideally pins should be placed obliquely along the lateral intramuscular septum so that the pin transfixes the least amount of muscle. For extremely unstable fractures a frame may be double stacked to increase stiffness and rigidity. A minimum of two pins are placed distal and proximal to the fracture. Using traction and manipulation, the fracture is reduced and the clamps tightened. The pins are connected to a 9.5 mm carbon rod with the 4.0mm-6.0 mm pin to rod clamps and definitively tightened. Independent Pin Placement For Femoral Shaft Fractures (Adjustments And Fine-Tuning Can Be Made Using This Technique) Midshaft Femur Single Stack (Anterior View) Alternatively, the pin can be placed freehand in each fragment using a short 9.5 mm carbon rod and two 4.0mm-6.0 mm pin clamps. A Rod-to-Rod Clamp is then used to connect the two shorter bars together. The fracture is reduced using manual traction and manipulation. Then all clamps are tightened. This frame is typically double stacked to increase frame stability. NOTE: Picture shown is for demonstration purposes only. This example would require perfect reduction. 16

19 Tibia Fractures, Midshaft Fractures Vascular injury Severe soft tissue compromise Patients who cannot physiologically tolerate an extended surgical procedure Highly contaminated wound Independent Pin Placement Single Stacked Tibial Fixation Tibial pins are usually placed either in an anteromedial direction starting on the anteromedial face of the tibia or in an anteroposterior direction starting just medial to the tibial crest. A minimum of two pins are placed freehand in each fracture fragment and connected to a Rod using 4.0mm-6.0 mm Pin-to- Rod Clamps. The two Rods are then connected using a Rod-to- Rod Clamp. A reduction is performed using manual traction and all clamps are definitively tightened. 17

20 Surgical Technique (Continued) Independent Pin Placement Double Stacked Tibial Fixation Tibial pins are usually placed either in an anteromedial direction starting on the anteromedial face of the tibia or in an anteroposterior direction starting just medial to the tibial crest. The two Rods are then connected using a Rod-to-Rod Clamp. A reduction is performed using manual traction and all clamps are definitively tightened. To increase the stiffness of the frame a second rod can be used. Midshaft Tibia Single Stack (Medial View) The fracture should be preliminarily reduced, then the most distal and proximal pins are placed in a colinear fashion. Reduction is then reassessed and clamps tightened. Finally, the two pins closest to the fracture are placed through pin clamps to ensure correct positioning and to maintain reduction. The clamps are then tightened. Midshaft Tibia Double Stack (Anterior View) 18

21 Elbow Spanning Frame Open fractures Severe soft tissue compromise Patients who cannot physiologically tolerate internal fixation Highly contaminated wounds The humeral pins are placed from lateral side of the arm while when in the distal humerus pins can be place either from the lateral side or posteriorly. Because of potential damage to radial nerve the pins must be placed using open incisions with the bone visualized and using guides to protect the neurovascular structures. Ulna pins can be placed percutaneously through the subcutaneous border of the ulna. A simple single stacked frame is usually sufficient for the elbow. A reduction is performed using manual traction and all clamps are definitively tightened. Pin-To-Bar Clamps are attached to all the pins and then two carbon fiber rods are attached and tightened. If a third rod is needed to make a connection between these two rods, it can be used. Elbow Spanning Frame (Lateral View) 19

22 Surgical Technique (Continued) Knee Spanning Anterior Frame (For Temporizing Fixation) Complex open distal femur fractures not amenable to acute fixation Unstable knee dislocation Complex tibial plateau fractures with soft tissue compromise Distal femur and proximal tibial fractures with instability The most important concept to keep in mind when placing a knee spanning frame is to try to keep pins away from the zone of injury whenever possible. In addition, pins should be kept away from the future sites of internal fixation. While this may sacrifice stability by not having pins close to the fracture site it will minimize potential complications. Another key concept is to make sure no pin is placed intra-articular within the knee joint. If a large flash of blood is returned when placing the triple sleeve, this typically indicates you are in the supra patellar pouch and the pin should not be placed in this location but moved more proximal. The next pins will be placed in the tibia away from the fracture and all future internal fixation sites, using the same technique as for the proximal femur. Anterior or anteromedial placement is used. A pin to bar clamp is then applied to each pin, keeping clearance for soft tissue maintenance. Once the pin clamps are in place, two 9.5 mm carbon bars are placed into the clamps one proximal and one distal that will extend pass the knee joint. Where the two carbon rods meet at or near the knee joint a bar to bar clamp is used to attach them together. If the rod do not meet close enough together then a smaller 9.5 mm carbon rod with two bar to bar clamps may be used to attach all rods together. Using traction and manipulation, the fracture may be reduced and all the clamps tightened definitively. Care should be taken to keep the knee joint flexed approximately 15 to relax the posterior neurovascular if needed. To make this a definitive frame all that is needed to double stack the frame. When spanning the knee for a distal femur fracture the frame is mounted on the proximal femur and proximal tibia while when treating the proximal tibia the frame is mounted on the distal femur and distal tibia. By following these general rules the concepts discussed above can be maintained. The femoral pin insertion sites are identified as proximal to all fractures and all future internal fixations. Pins are inserted in the anterior or anterior lateral surface of the femur using triple stacked trocar and sleeve as stated previously, then using the independent pin placement technique for pin to bar clamps. Spanning Knee (Medial View) Spanning Knee (Anterior View) 20

23 Ankle Spanning Frame With Transfixing Screw (For Temporizing Fixation) Distal tibia fracture Plafond fracture with or without fibula fixation Unstable ankle fracture or dislocations Severe soft tissue compromise Tibial pin site should be planned in accordance with secondary or definitive protocols in mind. Pins are inserted into the anteromedial or anterior surface of the tibia, using triple stacked trocar and sleeve as stated previously. Two pins are placed independently while staying out of the zone of injury and work area. A pin to bar clamp may be attached to each pin in the tibia at this time. A 4.0 mm, 5.0 mm, or 6.0 mm transfixing screw may be used in the calcaneous. (When using the 6.0 mm transfixing screw do not use the soft tissue sleeve the screw threads are 7.0 mm the sleeve is for a 6.0 mm screw) A small incision is made posterior and distal to the neurovascular bundle, and blunt dissection is made down to the bone. Following pin insertion protocol the calcaneal transfixing screw is inserted in to the bone parallel to the ankle joint. A pin to bar clamp is now attached to medial and the lateral side of the transfixing screw. A 9.5 mm appropriate length carbon rod, is now attached from one side of the transfixing screw to the proximal screw in the tibia. The next 9.5 mm rod is connected to the inferior pin in the tibia and other side of the transfixing screw. Apply traction to the tibia along its long axis, using the calcaneal transfixing screw. Once adequate reduction is achieved, tighten all clamps. All clamps should be checked for definitive locking. Spanning Ankle Transfixing Screw Frame (Anterior View) NOTE: A smaller screw may be placed in the base of the first metatarsal, and attached to a supplemental pin to bar clamp and rod then attached to the existing frame to help keep the foot out of eqinnus. 21

24 Ordering Information System Tray (Complete) Description Set Qty Vision Pin-To-Bar Fixation System Tray 1 (Consists Of Lower, Middle & Upper Tier) LOWER Tier Description Set Qty Carbon Fiber Rod, 9.5 mm Dia. x 150mm Carbon Fiber Rod, 9.5 mm Dia. x 200mm Carbon Fiber Rod, 9.5 mm Dia. x 250mm Carbon Fiber Rod, 9.5 mm Dia. x 300mm Carbon Fiber Rod, 9.5 mm Dia. x 350mm Carbon Fiber Rod, 9.5 mm Dia. x 400mm Carbon Fiber Rod, 9.5 mm Dia. x 500mm * Carbon Fiber Rod, 9.5 mm Dia. x 600mm N/A SLM Rapid Rod-To-Rod Clamp Hole Clamp Hole Clamp Clamp 3/5 Post SLM Rapid 4.0mm-6.0mm 20 Pin-To-Rod Clamp UPPER Tier Description Set Qty mm x 240 mm Long Drill Bit (A/O) mm x 240 mm Long Drill Bit (A/O) Transfixing Screw 4.0 mm x 350 mm Transfixing Screw 5.0 mm x 350 mm Transfixing Screw 6.0 mm x 350 mm TS Soft Tissue Sleeve (60mm) TS Soft Tissue Sleeve (100mm) * TS Soft Tissue Sleeve (125mm) N/A TS 3.2 mm Drill Sleeve (60mm) TS 3.2 mm Drill Sleeve (100mm) TS 4.8 mm Drill Sleeve (60mm) TS 4.8 mm Drill Sleeve (100mm) * TS 4.8 mm Drill Sleeve (125mm) N/A TS Trocar For 3.2 mm Drill (60mm) TS Trocar For 3.2 mm Drill (100mm) TS Trocar For 4.8 mm Drill (60mm) TS Trocar For 4.8 mm Drill (100mm) * TS Trocar For 4.8 mm Drill (125mm) N/A MIDDLE Tier Description Set Qty mm Allen Wrench mm Allen Wrench (Low Profile) Ratcheting T-Handle (Square Drive) mm Hex Shaft Square Shaft mm Wrench mm Quick Wrench C/D Strut (30mm) Bent U-Bar (190mm) Bent U-Bar (220mm) Bent U-Bar (250mm) C/D Wrench mm Bone Screw Driver mm Bone Screw Driver mm Ball Hex Shaft (Square Drive) mm Ball Hex Shaft Long (Square Drive) 2 Sterilization Tray Description Qty Vision Pin-To-Bar Tray (Empty) 1 Optional Components And Instruments (Not Included In Set) Description Qty.* Telescoping Bone Screw Post Ring Connector Assembly mm Connector Rod mm Connector Rod mm Connector Rod Double Rod Connector Vision 9.0 mm Wrench Vision 5.0mm/13 mm L-Wrench Vision L-Bar 1 * Optional In # Not Packed In Set 22

25 DFS Bone Screws 6.0mm/5.0 mm Tapered Cortical Bone Screws w/6.0 mm Shank Drill Size: 4.8 mm (Continued) 6.0mm/5.0 mm Tapered Cortical Bone Screws w/6.0 mm Shank Drill Size: 4.8mm A T Cortical-220/30 A T Cortical-220/40 A Cortical-90/30 A Cortical-220/50 A Cortical-90/40 A T Cortical-220/50 A Cortical-100/30 A Cortical-220/60 A Cortical-100/40 A Cortical-110/30 A Cortical-110/40 A Cortical-110/50 A Cortical-120/40 A Cortical-130/30 A Cortical-130/40 A T A T A T A T A T A T A T Cortical-220/60 Cortical-250/30 Cortical-250/40 Cortical-250/50 Cortical-250/60 Cortical-250/80 Cortical-250/100 A Cortical-130/50 A Cortical-300/60 A Cortical-130/60 A Cortical-130/70 A Cortical-140/80 4.5mm/3.5 mm Tapered Cortical Bone Screws w/6.0 mm Shank Drill Size: 3.2mm A Cortical-140/90 A Cortical-150/30 A Cortical-150/40 A Cortical-60/20 A Cortical-70/20 A T Cortical-150/40 A Cortical-80/20 A Cortical-150/50 A Cortical-80/30 A T Cortical-150/50 A Cortical-80/40 A Cortical-150/60 A Cortical-160/30 A Cortical-160/40 A Cortical-160/50 A Cortical-100/20 A Cortical-100/40 A Cortical-120/20 A Cortical-120/40 A Cortical-170/40 A Cortical-170/60 A Cortical-180/30 A Cortical-180/40 A Cortical-180/50 A Cortical-180/60 A Cortical-200/50 A Cortical-200/60 Catalog numbers ending in T are Trocar tipped (self-drilling) screws. All bone screws are tapered. 23

26 Ordering Information (Continued) 6.0mm/5.0 mm Tapered Cancellous Bone Screws w/6.0 mm Shank Drill Size: 3.2mm 3.3mm/3.0 mm Tapered Cortical Bone Screws w/4.0 mm Shank Drill Size: 2.7mm B Cancellous-90/30 B Cancellous-100/30 B Cancellous-100/40 B Cancellous-110/40 A Cortical-70/15 A Cortical-70/20 A Cortical-80/20 A Cortical-80/35 B Cancellous-110/50 B Cancellous-120/40 B Cancellous-120/60 3.3mm/3.0 mm Tapered Cortical Bone Screws w/4.0 mm Shank Trocar Tipped Drill Size: 2.7mm B Cancellous-130/40 B Cancellous-130/50 B Cancellous-130/60 B Cancellous-140/50 B Cancellous-150/60 A T A T A T Cortical-70/20 Cortical-80/25 Cortical-80/35 B Cancellous-160/70 B Cancellous-160/90 3.0mm/2.5 mm Tapered Cortical Bone Screws w/4.0 mm Shank Drill Size: 2.0mm B Cancellous-170/80 B Cancellous-180/90 B Cancellous-180/100 A Cortical-70/20 A Cortical-90/40 B Cancellous-200/80 B Cancellous-200/90 3.5mm/3.2 mm Tapered Cortical Bone Screws w/6.0 mm Shank Drill Size: 2.9mm A T A T A T A T A T Cortical-90/30 Cortical-70/20 Cortical-80/20 Cortical-80/35 Cortical-90/40 A Cortical-60/20 A Cortical-70/20 A Cortical-80/30 A Cortical-90/40 Catalog numbers ending in T are Trocar tipped (self-drilling) screws. All bone screws are tapered. 24

27 3.0mm/2.5 mm Tapered Cortical Bone Screws w/6.0 mm Shank Trocar Tipped Drill Size: 2.0mm 6.0mm/5.0 mm Tapered Hydroxyapatite Cortical Bone Screws w/6.0 mm Shank Drill Size: 4.8 mm (Continued) A T Cortical-70/20 HAA Cortical-180/50 A T Cortical-90/40 HAA Cortical-180/60 HAA Cortical-200/30 Threaded Wires (Package Of 4) HAA Cortical-200/40 HAA Cortical-200/50 M Self-Drilling-70/15 M Self-Drilling-100/15 DFS Bone Screws Surgical Trays HAA HAA HAA HAA Cortical-200/60 Cortical-200/80 Cortical-220/50 Cortical-220/60 HAA Cortical-250/ Cortical 6/5 Bone Screw Surgical Tray Cancellous 6/5 And Aux. Cortical Bone Screw Tray Bone Screw Surgical Tray HAA HAA HAA HAA Cortical-250/40 Cortical-250/50 Cortical-250/60 Cortical-300/60 6.0mm/5.0 mm Tapered Hydroxyapatite Cortical Bone Screws w/6.0 mm Shank Drill Size: 4.8mm HAA Cortical-100/30 HAA Cortical-110/30 HAA Cortical-110/40 HAA Cortical-110/50 HAA Cortical-120/40 HAA Cortical-130/30 HAA Cortical-130/40 HAA Cortical-130/50 HAA Cortical-150/20 HAA Cortical-150/30 HAA Cortical-150/40 HAA Cortical-150/50 HAA Cortical-150/60 HAA Cortical-160/30 HAA Cortical-180/30 HAA Cortical-180/40 6.0mm/5.0 mm Tapered Hydroxyapatite Cancellous Bone Drill Size: 3.2mm HAB Cancellous-100/30 HAB Cancellous-110/40 HAB Cancellous-110/50 HAB Cancellous-120/40 HAB Cancellous-120/60 HAB Cancellous-130/40 HAB Cancellous-130/60 HAB Cancellous-140/50 HAB Cancellous-150/60 HAB Cancellous-160/70 HAB Cancellous-160/90 HAB Cancellous-170/80 HAB Cancellous-200/80 HAB Cancellous-200/90 Catalog numbers ending in T are Trocar tipped (self-drilling) screws. All bone screws are tapered. 25

28 Ordering Information (Continued) 3.0mm/2.5 mm Tapered Cortical Bone Screws w/4.0 mm Shank Drill Size 3.2mm w/3.0 mm Shank Trocar Tipped Drill Size: 2.0mm SD Cortical-80/20 M T Cortical-50/18 SD Cortical-100/30 M T Cortical-60/20 SD Cortical-120/40 M T Cortical-60/25 SD Cortical-140/40 M T Cortical-60/30 M T Cortical-70/20 w/4.0 mm Shank Drill Size: 2.7mm M T Cortical-70/25 M T Cortical-70/30 SD Cortical-70/20 SD Cortical-80/35 2.5mm/2.0 mm Tapered Cortical Bone Screws w/3.0 mm Shank Trocar Tipped Drill Size: 1.6mm M T Cortical-45/20 Self-Drilling, Self Tapping Bone Screws w/6.0 mm Shank Drill Size 4.8mm SD SD SD SD Cortical-150/50 Cortical-180/60 Cortical-200/70 Cortical-250/80 w/6.0 mm Shank Drill Size: 3.8mm SD SD SD SD SD SD Cortical-120/30 Cortical-150/50 Cortical-180/50 Cortical-200/80 Cortical-250/50 Cortical-250/80 Catalog numbers ending in T are Trocar tipped (self-drilling) screws. All bone screws are tapered. 26

29 Sterilization The DynaFix Vision Unilateral System and the DynaFix Vision External Fixation System are provided non-sterile and must be sterilized prior to use. All packaging materials must be removed prior to sterilization. All fixator components should be sterilized in a loosened state such that components may move freely. The following steam sterilization parameters are recommended. Cycle: Vacuum Steam Temperature: 270 F/(132 C) Time: 8 minutes Drying time: 20 minutes Repeated sterilization of carbon fiber reinforced epoxy is not recommended. Individuals or hospitals not using the recommended method, temperature, and time are advised to validate any alternative methods or cycles using an approved method or standard. 27

30 Further Information The Vision External Fixation System is a modular external fixator intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality. Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician. This brochure describes the surgical technique used by Attila Poka, M.D. and Michael Sirkin, M.D. Biomet Trauma as the manufacturer of this device, does not practice medicine and does not recommend this product or any specific surgical technique for use on any individual patient. The surgeon who performs any implant procedure is responsible for determining the appropriate products(s) and utilizing the appropriate technique(s) for said implantation in each individual patient. WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. For further information, please contact the Customer Service Department at: Biomet Trauma 56 East Bell Drive P.O. Box 587 Warsaw, Indiana x

31

32 All trademarks herein are the property of Biomet, Inc. or its subsidiaries unless otherwise indicated. This material is intended for the sole use and benefit of the Biomet sales force and health care professionals. It is not to be redistributed, duplicated or disclosed without the express written consent of Biomet. For product information, including indications, contraindications, warnings, precautions and potential adverse effects, see the package insert and Biomet s website. Responsible Manufacturer Biomet, Inc. P.O. Box E. Bell Drive Warsaw, Indiana USA Rx only Biomet Orthopedics Form No. BMET REV