Biomet. Vision Pin-To-Bar System. Surgical Technique. Calcaneal Reduction Frame

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1 Biomet Vision Pin-To-Bar System Surgical Technique Calcaneal Reduction Frame

2 One Surgeon. One Patient. Over 1 million times per year, Biomet helps one surgeon provide personalized care to one patient. The science and art of medical care is to provide the right solution for each individual patient. This requires clinical mastery, a human connection between the surgeon and the patient, and the right tools for each situation. At Biomet, we strive to view our work through the eyes of one surgeon and one patient. We treat every solution we provide as if it s meant for a family member. Our approach to innovation creates real solutions that assist each surgeon in the delivery of durable personalized care to each patient, whether that solution requires a minimallyinvasive surgical technique or advanced biomaterials. When one surgeon connects with one patient to provide personalized care, the promise of medicine is fulfilled.

3 Biomet Vision Pin-To-Bar System Contents System Overview...2 Indications...2 Procedural Introduction...2 Pre-operative Planning...3 Incision...3 Transfixing Pin Insertion...4 Drill Preparation...6 Pin Insertion...7 Pin Clamp...8 U-Bar Attachment...10 Rod Connector...11 Distraction and Reduction...11 Posterior Facet Elevation...12 Metatarsal Fixation...13 Neutral Ankle Alignment...14 Post-op Care

4 Biomet Vision Pin-To-Bar System System Overview The Biomet Vision Pin-To-Bar Fixation System allows independent pin placement for simple, quick, and effective application of external fixation. The Biomet Vision System is versatile enough to be used as both temporary and definitive fixation. Definitive fixation uses include unilateral single bone fixation and hybrid configuration. It can also be applied to open book pelvic injuries as a resuscitive frame or a definitive fixator. For delayed open reconstruction in periarticular fractures, the Biomet Vision Pin-To-Bar Fixation System functions as an excellent means of temporizing fracture management to allow for soft tissue healing, as well as the opportunity to be at home while waiting for their procedure. The system helps allow the surgeon the ability to release patients from the hospital quickly, then readmit for a well-planned surgery or transfer to the appropriate physician. Indications The Biomet Vision Pin-To-Bar Fixation System is intended for use in the treatment of bone conditions including osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by the use of the external fixation modality. Procedural Introduction This calcaneal fracture technique was designed to simplify the traditional ORIF of the calcaneus and preserve limb function by minimizing operative trauma to anatomical structures. It combines the use of a simple multiplane external fixator for reduction of the varus deformity and of height loss, with minimal incision surgery to elevate the posterior facet. This surgical technique and postoperative protocol are utilized by John Torregrosa, DPM, FACFAS, FACFAOM. Biomet as the manufacture of this device does not practice medicine. Each surgeon is responsible for determining the appropriate device and technique to utilize on each individual patient. 2

5 Figure 1 Pre-operative Planning Review the X-rays and determine that there is a large enough section of the posterior calcaneus for a 6.0 mm transfixing screw (Figure 1). Access potential screw site location based on fracture pattern, involved bone and associated safe, soft tissue corridor. Position the patient in the supine position and prep and drape in the usual sterile fashion. Incision Make a small incision on the medial aspect of the posterior calcaneal fragment, proximal to distal to minimize the chance of damage to the calcaneal nerve. Use blunt dissection to spread the tissue to give a clear opening for the transfixing pin. 3

6 Biomet Vision Pin-To-Bar System Figure 2 Figure 3 Figure 4 Transfixing Pin Insertion Under power, insert a 6.0 mm transfixing screw from medial to lateral. Apply screw in a slightly varus orientation to match the varus deformity, which occurs with this type of fracture (Figure 2). Final posterior view will have varus orientation (Figure 3). As the lateral skin tents when the screw starts to exit, make a small incision over the tip to allow the transfixing screw to pass through (Figure 4). Note: When inserting the transfixing screw, utilize the split soft tissue sleeve to allow passage of the threaded portion of the screw. 6.0 mm Transfixing Screw (14285) Split Soft Tissue Sleeve (Vision FootRing System) (21460) 4

7 Figure 5 Figure 6 Under fluoroscopy, check to make sure the threads are centered in the calcaneus (Figure 5). A ratcheting T-handle is included in the Biomet Vision Pin-to-Bar tray to facilitate easy screw insertion. Remove the modular drill tip of the transfixing screw utilizing a T-handle (Figure 6). 5

8 Biomet Vision Pin-To-Bar System Figure 7 Drill Preparation In the distal 1 / 3 of the tibia, just medial to the anterior crest, make a small incision from superior to inferior for the insertion of a 6/5 mm half pin. Stack a drill sleeve within a soft tissue sleeve and insert this assembly into the incision in preparation for drilling. Using a trocar, create a small pilot dimple by tapping the hammer on the tip of the trocar stack to facilitate initial drilling. Remove the trocar and drill bicortically using the 4.8 mm drill bit. Note: The drill bit should pass in an anterior to posterior direction with a slight medial to lateral deviation (Figure 7). Take care not to drill into the soft tissue behind the second cortex. Soft Tissue Sleeve, 4.8 mm Drill Sleeve and Trocar Stack Soft Tissue Sleeve ( ) 4.8 mm Drill Sleeve ( ) Trocar ( ) 6

9 Figure 8 Pin Insertion Remove the drill bit and drill sleeve and insert an appropriately sized 6/5 mm half pin into the prescribed screw path. Under fluoroscopy, place the screw two threads past the far cortex and stop (Figure 8). Note: Do not use power to insert the 6/5 mm bone screws. Doing so increases the risk of driving screws excessively beyond the far cortex. Because these screws are conical, they should not be backed out. Backing out conical screw may compromise purchase and lead to loosening postoperatively. Ratcheting T-wrench with Screw Retaining Tip Ratcheting T-handle (03121) Bone Screw Driver ( ) 6/5 mm Bone Screw 7

10 Biomet Vision Pin-To-Bar System Figure 9 Pin Clamp Place a soft tissue sleeve in the bottom hole of a 3-hole multi-pin clamp and place over the previously placed tibial screw. Place soft tissue sleeves and drill guides in the remaining holes in preparation for drilling. Make small stab incisions from superior to inferior for insertion of each remaining 6/5 mm half pin. Insert the 4.8 mm drill bit into the proximal drill sleeve and drill bicortically. Remove the drill bit and drill sleeve and insert a 6/5 mm half pin through the soft tissue sleeve. Once bicortical half pin purchase is achieved, repeat the above step for the middle screw (Figure 9). After each of the screws have been inserted, check screw placement under fluoroscopy with a lateral view to confirm proper position and depth. The clamp must be tightened after all screws are in place and all soft tissue sleeves have been removed. Note: It is important to keep the clamp an appropriate distance from the skin for swelling and pin care. 3-Hole Pin Clamp (14060) 8

11 Figure 10 Place the posts on either side of the 3-hole clamp (Figure 10). Using an Allen wrench, definitively tighten each post. 2-Clamp 3/5 Post ( ) 9

12 Biomet Vision Pin-To-Bar System Figure 11 Figure 12 U-Bar Attachment Attach a U-Bar to the 6.0 mm transfixing screw using two Pin-To-Bar Clamps, pointing the bar upward (Figures 11 and 12). Ensure the pin-to-bar clamp is attached as close to the first bend as possible, while leaving space for additional clamps anteriorly (Figure 12). Bent U-Bar 190 mm (21280) 220 mm (21285) 250 mm (21290) Pin-to-Bar Clamp ( ) 10

13 Figure 13 Figure 14 Rod Connector On the lateral side of the ankle, use a bar-to-bar clamp to fixate the 9.5 mm carbon rod to the remaining anterior portion of the U-Bar. At the proximal interface (post extending from 3-hole pin clamp), use a bar-to-bar clamp to connect the distal post end to the carbon rod (Figure 13). Repeat this procedure and assembly on the medial side. Distraction and Reduction With both hands, grab the 6.0 mm transfixing screw, distract the calcaneus to reduce the fracture through ligamentotaxis, reducing the varus deformity and creating arthrodiastasis. The direction of distraction should be mostly plantar but somewhat posterior (Figure 14). While tension is applied, have an assistant tighten all bar-to-bar and pin-to-bar clamps to hold reduction. Confirm reduction of deformity and alignment of the calcaneal body with an axial view under fluoroscopy. 9.5 mm Carbon Rod (14160) Bar-to-Bar Clamp (14600) 11

14 Biomet Vision Pin-To-Bar System Figure 15 Figure 16 Posterior Facet Elevation After reduction is accomplished, make a small incision under the posterior facet on the lateral aspect of the calcaneus, taking care to avoid the peroneal tendons. Using a freer or key elevator, elevate the posterior facet against the talus under fluoroscopy (Figure 15). When the posterior facet position has been improved, insert bone graft material of choice (including InterGro DBM*) (Figure 16). Note: If possible, elevate the entire posterior facet at once by placing the instrument far enough medially before manipulating the facet. Elevation of the facet may be better achieved by applying pressure in a slightly anterior and then dorsal motion. Significant pressure may be applied using the talar component of the posterior facet as a template. 12

15 Figure 17 Figure 18 Figure 19 Metatarsal Fixation Under fluoroscopy, find the center of the base of the first metatarsal (Figure 17). From the medial side, make a small incision from proximal to distal. Perform blunt dissection, prepare and insert an appropriately sized transfixing pin under power from medial to lateral avoiding joints and capturing at least three metatarsals. When the transfixing pin tents the skin on the lateral side, make a small incision from proximal to distal to allow for exiting of the pin. Note: When inserting the transfixing pin, utilize the split soft tissue sleeve to allow passage of the threaded portion of the pin. Under fluoroscopy, check to make sure the threads. if possible, pass through the first three metatarsals. If needed, the tip of the pin can be cut using large bolt cutters. Next, attach a pin-to-bar clamp fairly close to the soft tissue on the medial side of the metatarsal transfixing pin. Place a 9.5 mm carbon rod onto the pin-to-bar clamp. Use a bar-to-bar clamp proximally to attach this carbon rod to the central side of the post. If unable to attach to the post, the carbon rod may alternatively be connected to the carbon rod connecting the U-bar to the post. Duplicate this procedure and assembly on the lateral side (Figures 18 and 19). 13

16 Biomet Vision Pin-To-Bar System Figure 20 Figure 21 Neutral Ankle Alignment While these clamps and bars are provisionally held in place, dorsiflex the foot to achieve a neutral ankle position to avoid an equinus deformity. Once neutral ankle alignment is achieved, lock the clamps to maintain this position. Finally, review the construct s stability and ensure that all clamps are definitively tightened. Close the incision on the lateral side of the calcaneus in layers and dress all pin sites using standard protocol (Figure 20). Post-op Care Daily pin care after first dressing change Non-weight bearing for one to three weeks Partial to full weight bearing with crutches or walker pad over the next one to two weeks when deemed appropriate by the treating surgeon The frame should be removed when the fracture has healed radiographically, typically in six to eight weeks Walker Pad (21235) 14

17 Biomet Trauma P/N Interpace Parkway Rev H Parsippany, NJ DYNAFIX VISION AND UNILATERAL SYSTEMS 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. Additional indications for the Biomet Vision FootRing 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) CONTRAINDICATIONS Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions. Authorized European Representative: Biomet UK Ltd. Waterton Industrial Estate Bridgend CF31 3XA, UK Biomet Osteobiologics LD Interpace Parkway Rev A Parsippany, NJ / INTERGRO DBM INDICATIONS FOR USE InterGro DBM products are to be used for filling bony voids or gaps in the extremities and pelvis that are not intrinsic to the bony stability of the structure, and as an allograft extender in the spine. InterGro Plus may also be used as a bone void filler in the spine (posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to bone. InterGro DBM may also be used for filling craniofacial defects and craniotomies that are no larger than 25cm2. Te amount of InterGro DBM products to be used should be based on the type of procedure and size of the graft site. CONTRAINDICATIONS InterGro DBM products are contraindicated in patients with incomplete skull growth. InterGro DBM products are contraindicated if active or latent infection is observed in or surrounding the implantation site. For additional information call Biomet Osteobiologics All trademarks are the property of Biomet, Inc. or one of its subsidiaries, unless otherwise indicated. Allowash is a registered trademark of LifeNet Copyright EBI, LLC. All rights reserved. All trademarks are the property of Biomet, Inc. or one of its subsidiaries, unless otherwise indicated. The information contained in this package insert was current on the date this brochure was printed. However, the package insert may have been revised after that date. To obtain a current package insert, please contact Biomet at the contact information provided herein.

18 Notes

19

20 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 physicians only and is not intended for patient distribution. 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/or Patient Risk Information in Biomet s website at Distributed by Biomet Trauma, Warsaw, Indiana x Interpace Parkway Parsippany, NJ Biomet Trauma biomettrauma.com Form No. BTR231032L REV RX Only

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