INEMA ΣΟΦΟΥΛΗ 83 ΡΟΔΟΣ τηλ: The Mayo Clinic Congruent Elbow Plates

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1 The Mayo Clinic Congruent Elbow Plates

2 THE FOR THE TREATMENT OF DISTAL HUMERUS AND OLECRANON FRACTURES Principle Based Internal Fixation Designed in conjunction with Shawn O Driscoll, M.D. and the Elbow Service at the Mayo Clinic, the Mayo Clinic Congruent Elbow Plates by Acumed incorporate Dr. O Driscoll s fracture fixation principles, which have been proven successful with over 12 years of clinical experience. The principles center around rigidly securing the articular fracture fragments and compressing them to the shaft with plates that are pre-contoured to match the anatomy. Current complications, including elbow stiffness, hardware failure, hardware prominence and delayed union or non-union, can be minimized with the successful application of these new, next-generation implants. Seven Technical Objectives 1) Every screw goes through a plate. 2) Each screw engages a fragment on the opposite side, that is also fixed to a plate. 3) Place as many screws as possible. 4) Screws should be as long as possible. 5) Screws should engage as many fragments as possible. 6) Compression is achieved between the fragments and the shaft. 7) The plates should be strong and stiff to resist bending prior to union. Both the lateral epicondylar (green) and medial epicondylar (fuscia) plates are pre-contoured to match the bone with little or no bending while achieving a low profile result and cortical screw interdigitation. The olecranon plates provide multiple fixation options in the proximal fragment with 2.7mm or 3.5mm cortical screws while allowing for compression in the slots shown above. Plates are pre-contoured to match the anatomy Tubular undersurface for plate/bone stability Low-profile screw plate interface Peri-articular holes clustered for maximum fragment fixation 2.7mm or 3.5mm screws for interdigitation Compression slots Slight under-contour Plate thickness optimized for each region Medial Epicondyle (Fuscia) Extra long (EL) Long (L) Short (S) Medium (M) Extended (EX) Lateral Epicondyle Left (L)- Blue Right (R)- Green Short (S) Long (L) LXL LL LS RS RL RXL EL L S M EX L S XL OLXL ORXL Olecranon (Aqua) Long (L) Standard (S) Extra Long (XL) Extra Long, Left (OLXL) Extra Long, Right (ORXL) Extra Long (XL) LC Coronoid Posterior (P)- Gold P RC Left (LC) Right (RC)

3 1 1) The articular fragments, which tend to be rotated toward each other in the axial plane, are reduced anatomically and provisionally held with or smooth Kirschner wires. It is essential that the wires be placed close to the subchondral level to avoid interference with later screw placement, and away from where the plates will be placed on the lateral and medial columns (see Fig. 2A). One or two strategically placed pins can be used to provisionally hold the distal fragments aligned with the shaft. 2A 2A) Medial and lateral precontoured plates are placed and held apposed to the distal humerus, while one smooth 2.0mm Steinmann pin is inserted through hole #2 (numbered from distal to proximal) of each plate through the epicondyles and across the distal fragments, to maintain provisional fixation of the plates to the distal fragments. 3 2B 2B) A screw is placed in the slotted hole (#5) of each plate, but not fully tightened, leaving some freedom for the plate to move proximally during compression later. Because the under surface of each plate is tubular in the metaphyseal and diaphyseal regions, the screw in the slotted hole only needs to be tightened slightly to provide excellent provisional fixation of the entire distal humerus. 3) Screws are inserted through hole #3 (numbered from distal to proximal) of the medial plate and across the distal articular fragments from medial to lateral, and tightened. This step is repeated on the lateral side, using hole #1. In young patients, 3.5mm cortical screws are used (to prevent breakage), whereas long 2.7mm screws are used in patients with osteoporotic bone. The distal screws should be as long as possible, passing through as many fragments as possible, and engaging the condyle or epicondyle of the opposite column.

4 4A 4A) Using a large tenaculum to provide interfragmentary compression across the fracture at the supracondylar level, the lateral column is first fixed. A screw is placed in dynamic compression mode (inset) in hole #4 (numbered from distal to proximal) of the lateral plate. Tightening this further enhances interfragmentary compression at the supracondylar level (converging arrows) to the point of causing some distraction at the medial supracondylar ridge (diverging arrows). 4B 4B) The medial column is then compressed in a similar manner using the large tenaculum, and a screw is inserted in the medial plate in dynamic compression mode. If the plates are slightly under contoured, they can be compressed against the metaphysis with a large bone clamp, giving further supracondylar compression. 5 5) All smooth Steinmann pins are removed, and the remainder of the screws are inserted. The distal screws interdigitate for maximum fixation in the distal articular fragments. A single long screw can be placed through hole #1 in the medial plate up into the shaft for compression. Post-op Protocol Immediately after closure the elbow is placed in a bulky non-compressive Robert-Jones dressing with an anterior plaster slab to keep the elbow in extension and the upper extremity is kept elevated thirty-six hours. After that, the Robert-Jones dressing is removed, an elastic nonconstrictive sleeve is applied over an absorbent dressing placed on the wound, and a program of continuous passive motion is started with the goal being able to flex and extend the elbow as much as tolerated in order to avoid fluid accumulation at the elbow region. A more complete post-op protocol is available upon request. Pre-op X-ray

5 Olecranon and Coronoid Plates for the Treatment of Ulna Fractures Olecranon Plates With the elbow flexed 90, the fracture* is reduced and the plate applied. The prongs in the proximal plate penetrate the triceps tendon and provide provisional fixation. A 2mm Kirschner Wire is drilled through the proximal hole of the plate and across the fracture site (either into the canal or penetrating the anterior metaphyseal cortex, as per surgeon preference). Alternatively, two.062 K-Wires can be placed across the fracture, one on each side of the plate. With provisional reduction confirmed, a 3.5mm screw is inserted into the slotted hole just distal to the fracture site and partially tightened. Next, two 2.7mm screws are inserted into the pair of the holes proximally (one on either side of the intramedullary 2mm K-Wire) aiming for the nonarticular surface of the tip of the olecranon, but not exiting the bone. Next, a 3.5mm screw is inserted into the shaft distally in compression mode (drilled eccentrically). The screw in the slotted hole can be loosened to permit plate movement during compression. If further compression is required, another screw can be placed in compression mode (drilling again eccentrically) through a hole distal to the fracture site, and tightened after loosening the first two screws. The 2mm K-Wire is removed and a 3.5mm or 2.7mm screw is inserted down the canal or into the anterior cortex distally. The remaining proximal holes are filled with 2.7mm screws which interlock in a grid-work with the other proximal screws to maximize fixation in the small proximal fragments. These should all point toward an extraarticular cortex, not toward the joint. The remaining 3.5mm cortical screws can be inserted distally and the K-Wires removed. *If the plate is being used to fix an osteotomy, it should be applied and screw holes drilled, then the plate removed prior to the osteotomy being performed. Note: The standard and extra-long plates sit partially on the triceps tendon, but do not compress it as the prongs hold those plates off the bone (a gap should be seen under the proximal tip on the x-ray). Coronoid Plates Coronoid fractures usually require reduction for optimum elbow function and stability. They are often comminuted. The coronoid can be exposed through an anteromedial approach. The fragments are reduced and provisionally held with one to three threaded titanium**.062 Kirschner Wires drilled from posterior to anterior. These are best placed while retracting the coronoid fragments to see the wires emerge into the fracture surface. They are then backed out to permit fracture reduction, then reinserted across the fracture site. The Mayo Congruent Coronoid Plate is then applied so that the sharp prongs grasp and buttress the section of the coronoid between its tip and its medial (sublime) tubercle on which the anterior bundle of the MCL inserts. The plate wraps around the brachialis tendon insertion onto the medial side of the ulna distally. While holding the plate reduced, the middle hole is drilled and a 2.7mm screw is inserted but not tightened. The distal tip is then pushed anteriorly, levering the proximal end to more securely buttress the coronoid fragments, and a screw is inserted in the distal hole but not tightened. The screw in the middle hole is then tightened, pulling the midportion of the plate down to finalize the buttressing. The distal screw is then tightened.the plate is flexible enough so that its contour will adjust itself while tightening this last screw. The titanium wires are then cut flush with the subcutaneous border of the ulna and burred to eliminate soft tissue irritation. The small coronoid plate is intended for isolated coronoid fractures and those associated with the terrible triad injury (elbow dislocation with fractures of the radial head and coronoid). Transolecranon fracture-dislocations involving the coronoid may require fixation with a longer plate extending down the shaft. **Titanium wires are used to avoid a galvanic reaction with the titanium screws, which could occur if stainless steel wires are used. These titanium wires are provided with the Mayo Clinic Congruent Elbow Plate System.

6 AcUMED Copyright 2002 Acumed, Inc. All rights reserved. Acumed is a registered trademark of Acumed. All other names and brands are the property of their respective owners. Printed in the USA. AcUMED 5885 NW Cornelius Pass Rd. Hillsboro, OR USA FBPL Effective 05/07/2002 Patents Pending

7 AcUMEDr MoDULAR HAND SYSTEM

8 MoDULAR HAND SYSTEM Since 1988,Acumed has been designing solutions to the demanding situations facing orthopedic surgeons, hospitals and their patients. Our strategy has been to know the indication, design a solution to fit, and deliver quality products and instruments. The Modular Hand System is the next extension of this philosophy. Designed to address specific indications throughout the hand, from the carpals to the phalanges, the Modular Hand System offers innovative fixation solutions. Ultimately encompassing both fracture and fusion fixation, the system is contained in a modular tray set that will allow for customization and expansion as future products are introduced. The launch of the system brings to orthopedics two unique plates designed for specific fusions of the hand: the Hub Cap Limited Wrist Fusion and MCP Fusion plates. CONTENTS Hub Cap 2 MCP Fusion Plate 4 System Features 5 Hub Cap Surgical Technique 6 MCP Fusion Plate Surgical Technique 11 Legal Information 15 The Hub Cap The Hub Cap Limited Wrist Fusion Plate was designed to provide outstanding fixation and a straightforward technique. As a targeted solution for four corner and other limited wrist fusions, the plate offers the kind of innovations upon which Acumed has built its reputation. Four corner fusions have been used with a high degree of success over the past 20 years to treat SLAC, SNAC and other arthritic conditions. Up to seven 2.1mm or 2.7mm screws secure the plate to the Capitate, Lunate, Hamate, and Triquetrum, These screws can in turn be locked down with the optional screw cover which threads into the center of the plate. Clinical outcomes have shown that plating is a highly stable and effective means to achieve a limited wrist fusion without either the complexity of screw procedures or long periods of immobilization due to the instability of K-Wires. 2

9 Variable Screw Placement is facilitated by the screw-plate interface and scalloped design which allows for maximized purchase in the four carpals. The enhanced screw placement, when combined with Acumed s 2.7mm or 2.1mm screws, makes for a solid construct that fits the patient. 50º 33º Provisional Stability During Insertion is achieved through both the K-Wire holes and the Plate Post. Creating this early stability ensures accurate screw placement and eliminates plate tilt, or dishing, which could lead to prominence of the plate above the dorsal surface of the carpals. Advanced Instrumentation includes a dual purpose reamer that captures and contains bone debris as it creates the spherical depression to prepare the fusion site for the Hub Cap. A unique bone graft harvester designed specifically for use on the distal radius is also included in the system. Center Hole enables using the post for provisional stability, removing it to pack bone graft, and locking of the screws with a cover all at the surgeon s discretion. Scalloped Holes enable placement of either 1 or 2 screws into each carpal, based on surgeon preference. Rounded and Polished Crown allows tendons to glide naturally over the top of the titanium plate, while grit blasted underside promotes bony ongrowth. Single Hole provides a dedicated starting point that facilitates accurate placement of the remaining screws. 3

10 MCP FUSION PLATE The Acumed MCP Plate is the first plate specifically designed for fusions of the 1st MCP joint of the thumb. Whether the indication is arthritis or chronic instability of the MCP or CMC joint, this plate offers excellent stability and enables early rehabilitation. Sharing its instruments and screws with the Hub Cap makes for a familiar procedure and a simple prep in the OR. Precontoured Plate Design helps to create desired flexion, maximizes screw placement, and minimizes OR time spent bending plates. 25 Low Profile Plate and Screw Design minimizes soft tissue irritation, which is especially important in this area with little tissue coverage. Highly Polished and Rounded surfaces allow the tendons of the thumb to glide across the plate without irritation or adhesion. Designed in conjunction with Dr. Miguel Pirela-Cruz, MD Chair of the Department of Orthopedic Surgery at the Texas Tech University School of Medicine in El Paso, Texas. 4

11 SYSTEM FEATURES Designed to address specific indications throughout the hand, from the carpals to the phalanges, the Modular Hand System offers innovative fixation solutions. Ultimately encompassing both fracture and fusion fixation, the system is contained in a modular tray set that will allow for customization and expansion as future products are introduced. Both current plates, as well as future additions to the system, use the same screws and instruments, making it highly flexible and surgeon friendly. Modular Tray Design allows for scalability and future expansion. Corresponding drills and screws are housed in their own modular tray to eliminate confusion in the OR. Modular Hand System Ordering Information: Implants PL-WF40 PL-WF50 PL-WF60 PL-MCPL PL-MCPR Screws CO-F2106 CO-F2108 CO-F2110 CO-F2112 CO-F2114 CO-F2116 CO-F2706 CO-F2708 CO-F2710 CO-F2712 CO-F2714 CO-F2716 Hub Cap Limited Wrist Fusion Plate Hub Cap Plate Post Hub Cap Screw Cover MCP Fusion Plate - Left MCP Fusion Plate - Right 2.1 mm x 6 mm Bone Screw 2.1 mm x 8 mm Bone Screw 2.1 mm x 10 mm Bone Screw 2.1 mm x 12 mm Bone Screw 2.1 mm x 14 mm Bone Screw 2.1 mm x 16 mm Bone Screw 2.7 mm x 6 mm Bone Screw 2.7 mm x 8 mm Bone Screw 2.7 mm x 10 mm Bone Screw 2.7 mm x 12 mm Bone Screw 2.7 mm x 14 mm Bone Screw 2.7 mm x 16 mm Bone Screw Instrumentation WF-0000 Tray Set & Instruments (No Implants) PL-SR39 Hub Cap Reamer Replacement Head PL-SR40 Hub Cap Reamer Assembly PL-SR41 Hub Cap Reamer Head Wrench PL-BG07 Bone Graft Harvester MTP-F mm Concave Joint Reamer MTP-M mm Convex Joint Reamer MTP-F mm Concave Joint Reamer MTP-M mm Convex Joint Reamer PL /2.7 mm Drill Guide Assembly MS-DC mm Quick Release Drill MS-DC mm Quick Release Drill MS-1210 Quick Release Handle HPC mm Quick Release Driver PL-PTACK Plate Tack MS-2211 Cruciform Driver Tip MS-2212 Cruciform Driver Sleeve MS-2210 Cruciform Driver Handle WS-0906ST.035" Guide Wire Stainless Steel WS-1106ST.045" Guide Wire Stainless Steel WS-1505ST.059" Guide Wire Stainless Steel 5

12 SURGICAL TECHNIQUE The Hub Cap This section offers Acumed s suggested method for implanting the Hub Cap Limited Wrist Fusion Plate from the Acumed Modular Hand System. For specific questions not addressed here, please contact your local Acumed representative or Acumed by phone at or on the web at Step 1: Create an entry site. Step 2: Fix Carpals with K-Wires. Gain access to the carpal bones. Stabilize carpals for reaming. Create an entry site central to the dorsal wrist, taking care to avoid the radial and ulnar nerves. Either a dorsal midline longitudinal or T incision may be used. In cases where scaphoidectomy is called for, care should be taken to protect the extrinsic ligaments while removing the scaphoid. Radial styloidectomy may be required as well. After exposing the capitate, lunate, hamate, and triquetrum, denude the cartilage between the four bones involved in the fusion. Provisionally fix the bones with.045 K-Wires as volar as possible. Suggested order for K-Wires: 1) Hamate to Capitate 2) Triquetrum to Lunate 3) Triquetrum to Capitate Neutral alignment along the capitolunate axis is crucial for obtaining unimpinged flexion once the wrist has fused. A K-Wire joystick may be used to aid in the dorsal rotation of the lunate. 6

13 Step 3: Ream the carpals. Create a recess to accommodate the plate. Center the reamer over the junction of the four carpals, targeting the center with the guide tip of the reamer. Under power, ream the carpals to the laser marks on the reamer. The tops of the carpals should lie between the two lines on the reamer head. This, along with placing the plate into the recess to check for prominence, ensures a sufficient plate depth below the dorsal surface of the carpals. Step 4: Pack the fusion site with autograft. Promote a fusion between the carpals. The bone graft harvester from the set may be used to harvest autogenous bone from the distal radius or the illiac crest. Pack the autograft into the reamed depression targeting the guide hole and joint surfaces to be fused. (As it cuts, the reamer will capture bone debris which keeps the fusion site clear and may provide a possible source of bone graft material.) 7

14 The Hub Cap Surgical Technique Step 5: Target the hamate and fix the plate with a K-Wire. Line up screw holes for maximum fixation. Place the Hub Cap into the depression and target the hamate with the single screw hole. Ensure that this first screw placement maximizes subsequent placement in the three other bones. When targeting, keep in mind that Acumed recommends a total of 7 screws for this procedureone in the single hole, and two for each of the scalloped slots, placed in the outer holes. Fix the plate provisionally with a.035 K-Wire(s) opposite the hamate to ensure its position. The K-Wire and plate post provide multiple points of provisional stabilization, securing the plate s position during both drilling and screw insertion. Step 6: Drill the hamate. Prepare the first hole and determine screw size. Using either end of the drill guide, drill into the hamate and measure depth. Holes should be drilled to within 2mm of the far cortex. Avoid bicortical drilling. Acumed recommends a total of 7 screws for this procedure - one in the single hole, and two for each of the the scalloped slots, placed in the outer holes. Screw placement ranges: Single hole: 50 vertical and 40 horizontal Scalloped slot: 33 vertical and 50 horizontal Tip: While 2.1mm screws are available, Acumed recommends using the 2.7mm screws and the accompanying drills and taps within the system. 2.1mm screws require a 1.5mm drill. 2.7mm screws require a 2.0mm drill. 8

15 Step 7: Insert hamate screw and target lunate. Secure first two points of fixation. Insert the first screw. Use the longest screws possible for maximum fixation. After inserting first screw, target lunate for next screw, drill, and insert. With two screws and the plate post as fixation, the plate is now stable enough to remove the K-Wire that had been used to provisionally stabilize the plate. Tip: In the case that a rescue solution is needed: 1. Redrill at a different angle 2. Place a 3rd screw into the middle scallop 3. Secure the screw with the screw cap 4. If using a 2.1mm screw, replace with a 2.7mm Step 8: Insert remaining screws and remove post. Secure remaining points of fixation. Using the same process, drill and insert screws into the remaining holes. Tighten all of the screws to ensure compression of the joint surfaces and promote fusion of the carpals. Recommended screw insertion order is: 1. Hamate 2. Lunate 3. Capitate 4. Triquetrum 5. Fill the remaining holes in any order The plate post may then be removed with the hex driver contained in the system, allowing autograft to be packed in the central plate hole. 9

16 The Hub Cap Surgical Technique Step 9: Assess final fixation. Post Op Protocol Review of procedure. View fixation under flouroscopy to ensure proper placement and test range of motion. (Optional) Lock down screws and autograft with the screw cover by inserting it into the central plate hole. After closure place arm in a bulky volar splint that immobilizes the wrist in a neutral position and elbow at 90º, yet enables early movement of the fingers. In approximately one week, remove sutures and replace medium splint with a removable short arm splint to allow an early range of motion and rehab. Splint should be used for three to four weeks. Periodic radiographs should be taken to check fusion of the four carpals. Normal activities may be resumed after fusion is determined to be successful. 10

17 SURGICAL TECHNIQUE The MCP Fusion Plate by Dr. Miguel Pirela-Cruz, MD This section offers Acumed s suggested method for implanting the MCP Fusion Plate from the Acumed Modular Hand System. For specific questions not addressed here, please contact your local Acumed representative or Acumed by phone at or on the web at Step 1: Create entry site. Step 2: Decorticate joint surfaces. Gain access to metacarpal and phalanx. Prepare surfaces for fusion. Create an entry site using a dorsal midline approach to the metacarpophalangeal joint. Continue the dissection sharply on the radial and ulnar aspects of the joint, excising the collateral ligaments and creating exposure to the joint. Drive a.059 K-Wire through each bone to act as a guide for the reamers. While the wire for the proximal phalanx should be driven centrally, the wire for the metacarpal should be driven obliquely at an angle equal to the desired angle of flexion. This should begin centrally and exit through the dorsal midline of the metacarpal. Decorticate the articular surfaces of the joint using the convex/concave reamers within the set. This creates a complementary surface for the fusion with minimal shortening of the thumb. Prior to reaming the ligaments should be released completely to maximize access and minimize any risk to the soft tissues. 11

18 MCP Fusion Plate Surgical Technique Step 3: Secure plate to proximal phalanx. Step 4: Drill the first hole. Determine positioning of the plate. Prepare the first hole for the screw. If necessary, contour plate to desired angle of flexion. The plate comes precontoured with a 25º angle. Secure the plate to the proximal phalanx using the plate tack in the most distal hole and check flexion. Using the appropriate end of the drill guide, drill the proximal phalangeal hole of the plate. Measure the depth of the hole and note the appropriate screw size that will sufficiently engage both cortices. Tip: 2.1mm screws require a 1.5mm drill. 2.7mm screws require a 2.0mm drill. 12

19 Optional Step 5: Insert the first screw. Repeat process for second. Step 6: Compress the joint, drill holes, and insert screws. Secure the plate to the proximal phalanx. Gain compression and fix the fusion site. Insert the appropriate screw through the plate and into the bone. Remove the plate tack. Repeat the drill and insertion process for the distal hole. While maintaining compression across the MCP joint, place the proximal portion of the plate along the radial side of the metacarpal. Drill and measure as before, inserting the proximal screw and then the distal. Option: If greater compression is desired a compression screw may be inserted obliquely from the medial side of the metacarpal across the fusion site and into the proximal phalanx. 13

20 MCP Thumb Plate Surgical Technique Step 7: Pack the fusion site with autograft. Post Op Protocol Promote union of the fusion site. After securing the plate to the metacarpal, insert a small amount of bone graft into the vicinity of the fusion mass. Ensure that the interphalangeal joint of the thumb is unrestricted in its motion and repair the extensor tendons. After closing, a sterile dressing and a protective dorsal splint are applied. In approximately one week the patient is placed in a thumb spica splint and referred to therapy. In therapy, a strong emphasis is placed on an early range of motion for both the interphalangeal and carpometacarpal joints. The thumb spica splint is discontinued in 4-6 weeks, after the patient is relatively comfortable. Option: a compression screw may be inserted obliquely if the surgeon desires. 14

21 Congruent Bone Plate System FOR THE PERSONAL ATTENTION OF THE OPERATING SURGEON DESCRIPTION: Acumed Bone plates, accessories, and screws are designed to provide fixation for fractures, fusions or osteotomies. INFORMATION FOR USE: Physiological dimensions limit the sizes of implant appliances. The surgeon must select the type and size that best meets the patient s requirements for close adaptation and firm seating with adequate support. INDICATIONS: The Acumed bone plate system includes plates and screws designed specifically for clavicle, humerus, radius, ulna, metacarpal, metatarsal, malleolus, tibia, fibula, metacarpals. The wrist fusion plate and accessories are designed specifically for fusion of the small bones of the hand including: hamate, capitate, lunate, triquetrum. CONTRAINDICATIONS: Active or latent infection. Osteoporosis, insufficient quantity or quality of bone/soft tissue. Material sensitivity. If suspected, tests are to be performed prior to implantation. Sepsis. Patients who are unwilling or incapable of following postoperative care instructions. This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. WARNINGS: For safe and effective use of this implant, the surgeon must be thoroughly familiar with the implant, the method of application, instruments, and the recommended surgical technique for this device. The device is not designed to withstand the stress of weight bearing, load bearing, or excessive activity. Device breakage or damage can occur when the implant is subjected to increased loading associated with delayed union, nonunion, or incomplete healing. Improper insertion of the device during implantation can increase the possibility of loosening and migration. The patient must be cautioned, preferably in writing, about the use, limitations, and possible adverse effects of this implant including the possibility of the device failing as a result of loose fixation and/or loosening, stress, excessive activity, or weight bearing or load bearing, particularly if the implant experiences increased loads due to delayed union, nonunion, or incomplete healing. The patient must be warned that failure to follow postoperative care instructions can cause the implant and/or treatment to fail. PRECAUTIONS: An implant shall never be reused. Previous stresses may have created imperfections which can lead to device failure. Instruments shall be inspected for wear or damage prior to usage. Protect implant appliances against scratching and nicking. Such stress concentrations can lead to failure. ADVERSE EFFECTS: Fracture of the implant due to excessive activity, prolonged loading upon the device, incomplete healing, or excessive force exerted on the implant during insertion. Implant migration and/or loosening. Metal sensitivity or histological or allergic reaction resulting from implantation of a foreign material. Pain, discomfort, or abnormal sensations due to the presence of an implant. Nerve damage resulting from surgical trauma. Necrosis of bone or bone resorption. Necrosis of tissue or inadequate healing. STERILITY: This product is provided nonsterile. Sterilization may be performed using one of the following methods. For a gravity displacement autoclave, set at 250º F (121ºC) for 30 minutes. For a prevacuum autoclave, set at 270º F (132ºC) for 4 minutes, or at 273ºF-279ºF (134ºC to 137ºC) for 3 minutes. Please consider your equipment manufacturer s written instructions for the specific sterilizer and load configuration being used, and current AORN standards and recommended practices. STORAGE INSTRUCTIONS: Store in a cool dry place, and keep away from direct sunlight. Prior to use, inspect product package for signs of tampering, damage, or water contamination. CAUTION: Federal Law (USA) restricts this product to sale by or on the order of a physician or hospital. Catalog Number Lot Number Use By See Instructions for Use Single Use Only Acumed, Inc 5885 NW Cornelius Pass Road Hillsboro, OR U.S.A. For product information AcUMEDr 5885 NW Cornelius Pass Road, Hillsboro, OR (888)

22 AcUMEDr Copyright 2002 Acumed, Inc. Acumed is a registered trademark and Hub Cap is a trademark of Acumed. All rights reserved. Patent pending. Printed in the USA N.W. Cornelius Pass Road Hillsboro, OR PCON Effective: 09/2002