Integra. Stainless Headed Compression Screw System SURGICAL TECHNIQUE

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1 Integra Stainless Headed Compression Screw System SURGICAL TECHNIQUE

2 Table of Contents Design Rationale...2 Indications...2 Contraindications...2 Surgical Technique Step 1: Inserting Guide Wire... 3 Step 2: Pre-Drilling (Optional)...4 Step 3: Countersinking Screw Head (Optional)...4 Step 4: Measuring Screw Length...4 Step 5: Inserting The Screw mm/4.5mm Stainless Headed Compression Screw Instrument Set mm/7.5mm Stainless Headed Compression Screw Instrument Set mm/4.5mm Integra Stainless Headed Compression Screw System mm/7.5mm Integra Stainless Headed Compression Screw System...9 Stainless Headed Compression Screw Precautions

3 Design Rationale The Integra 4.0mm/4.5mm Stainless Headed Compression Screw System consists of headed cannulated screws of 4.0mm and 4.5mm diameters. The Integra 6.5mm/7.5mm Stainless Headed Compression Screw System consists of headed cannulated screws of 6.5mm and 7.5mm diameters. All screws are designed to be self drilling with special cutting grooves that allows the screw to drill easily into the bone. Pre-drilling is recommended for juvenile or hard bone. Screws are self tapping both forward and backward, which facilitates easy removal. The implants, K-wires and drills are provided non-sterile and are single-use only. Instrumentation is provided to assist in the surgical implantation of the implants. It is important that the instruments used are those specifically designed for this device to ensure accurate installation. Indications The cannulated screws are intended for use over a guide pin or wire for bone fracture fixation and bone fragment fixation. The washers may be used with the screws in certain applications. The indications for the Integra Stainless Headed Compression Screws (Ø 4.0mm, 4.5mm, 6.5mm, and 7.5mm) include: Fractures of the wrist, ankle, elbow, and shoulder Metatarsal fractures and other fractures of the foot Condylar fractures Ligament avulsion injuries Fractures of small joints, such as: Minimally invasive reconstruction of fractures and joints Adjuvant for osteosynthesis in complex joint fractures Multi-fragment joint fractures Simple metaphyseal fractures Simple epiphyseal fractures such as:»» Fractures of the humeral head»» Pilon fractures»» Fractures of the radius»» Ankle fractures»» Navicular fractures Calcaneal and talar fractures Arthrodesis of the ankle Contraindications Inflammation, sepsis and osteomyelitis are absolute contraindications. Any other applications not covered by the indications and the medical literature are also contraindicated. In addition, the success of the operation may also be affected by: Unacceptably high risk for anesthesia Inadequate soft tissue coverage Acute or chronic systemic or localized infection / inflammation Vascular, muscular or neurologic disorders impairing the affected limb Any concomitant disorders possibly affecting implant function Osteopathy with loss of bone substance, such as severe osteoporosis Obesity: an obese patient may overload the implant to the point where the fixation or implant may fail Whenever the implant is impairing the anatomical structures or normal physiology Caution: Federal law restricts this device to sale by or on the order of a physician or practitioner. See package insert for full prescribing information 2

4 Surgical Technique As the manufacturer of this device, Integra does not practice medicine and does not recommend this or any other surgical technique for use on a specific patient. The surgeon who performs any procedure is responsible for determining and using the appropriate technique in each patient. Step 1 Inserting Guide Wire 1-1 Initial incision is made. Insert the obturator into the tissue protector, ensuring it is flush with the bone surface. Advance K-wire through the obturator using gentle and steady pressure to avoid bending the guide wire. Once appropriate reduction is achieved, remove the obturator from the tissue protector. 1-1 NOTE: The position of the K-wire defines the final position of the cannulated screw in the bone. NOTE: Always use a pre-measured K-wire. Manufacturing tolerances may influence the measurement and choice of the correct screw length. K-Wire Reference Guide Screw Diameter 4.0mm 4.5mm 6.5mm 7.5mm K-Wire Diameter 1.2mm 1.6mm 2.5mm 3.0mm Use of the Parallel Drill Guide: for 4.0 and 4.5mm Screws Unscrew the retaining nut of the parallel drill guide insert. Place the drill guide insert into the oblong hole of the parallel drill guide and secure with the retaining nut. Advance parallel drill guide along the guide wire. Fix desired position by moving the drill guide insert along the oblong hole and tighten the retaining nut. Insert the obturator into the circular hole on parallel drill guide. Advance K-wire through the obturator. Remove parallel drill guide insert and continue with screw length measurement. 1-3 Use of the Parallel Drill Guide: for 6.5mm and 7.5mm Screws Advance the parallel drill guide along the K-wire. Advance additional K-wires through the holes in the parallel drill guide. Remove parallel drill guide insert and continue with screw length measurement

5 Step 2 Pre-Drilling (Optional) 2-1 Although the screws are designed to be self drilling, pre-drilling is recommended for juvenile or hard bone to prevent damage to the screw during insertion as well as a loss of reduction due to the applied forces Use the cannulated drill bit that coincides with the appropriate screw diameter and respective drill sleeve. In order to avoid damaging the drill or K-wire, use low speed or drill manually using the ratcheting handle. Apply pressure continuously. 2-3 Remove tissue protector and drill sleeve. Step 3 Countersinking Screw Head (Optional) 3-1 When soft-tissue coverage and/or screw position demands further recess of the screw head, the countersink may be used. 3-1 If the angle of approach is too steep, the proximal cortex can be pre-drilled or the countersink may be utilized. Ideally, all screw cutting flutes should grip simultaneously to avoid damage to the screw. This step should be done prior to measuring as it may affect the correct screw length determination. Step 4 Measuring Screw Length 4-1 Slide the direct measuring device over the K-wire down to the bone. This will provide an accurate measurement of the required screw length. Make sure to account for potential deviations from compression and use of washers. Ensure that no soft tissue or liquid exists between the bone and the measuring device as it will alter the screw measurement. 4-1 Step 5 Inserting The Screw 5-1 Assemble the appropriate driver to the ratcheting handle. Slide the screw and the assembled screwdriver over the K-wire onto the bone. Insert the screw by turning the screwdriver clockwise. Always insert the screws manually. Using a power driver is not recommended. Once the screw is inserted, remove the K-wire. 5-1 For screw removal, always use a non-cannulated screwdriver. NOTE: In case the screw penetrates the bone too deeply, washers can be used to salvage the screw fixation and reduce tension peaks between the bone and screw head. Remove the screw with the K-wire still in place, slide the washer over the screw and reinstall. 4

6 4.0mm/4.5mm Stainless Headed Compression Screw Instrument Set 1. Threaded K-wire, Ø1.6, L K-wire, Ø1.2, L Cleaning Wire 4.5, Ø Cleaning Wire 4.0, Ø Screwdriver Cannulated 4.5, Hexagonal, ø Screwdriver Cannulated 4.0, Hexagonal, ø Drill 4.0, Ø Drill 4.5, Ø Drill 4.5, Ø Drill 4.0, Ø Countersink 12. Staple for Washers 13. Screw Forceps 14. Direct Measuring Device mm Cannulated Screws, Short Thread mm Cannulated Screws, Full Thread mm Cannulated Screws, Short Thread mm Cannulated Screws, Full Thread 19. Drill Guide Insert, Drill Guide Insert, Obturator, Obturator, Drill Sleeve 4.0, Ø Drill Sleeve 4.5, Ø Drill Sleeve 4.0, Ø Drill Sleeve 4.5, Ø Tissue Protection Sleeve 28. Parallel Drill Guide 29. Ratcheting Handle

7 6.5mm/7.5mm Stainless Headed Compression Screw Instrument Set 1. Cannulated Drill 7.5, Ø5.0, L Cannulated Drill 6.5, Ø4.4, L Countersink, 6.5/ Screwdriver Cannulated 6.5/7.5, hex Ø Washer I- Ø8.3, O- Ø Drill Sleeve Drill Sleeve Tissue Protection Sleeve 6.5/ Cannulated screwdriver 6.5/7.5, T-handle 10. Screw Holding Forceps mm Cannulated Screws, Full Thread mm Cannulated Screws, TL mm Cannulated Screws, TL mm Cannulated Screws, Full Thread mm Cannulated Screws, TL mm Cannulated Screws, TL Cleaning Wire 6.5, Ø Cleaning Wire 7.5, Ø K-wire Ø3.0mm, L K-wire Ø2.5mm, L Direct Measuring Device, 6.5/ Ratcheting Handle 23. Parallel Guide for K-wires, 6.5/ Obturator, Obturator,

8 4.0mm/4.5mm Integra Stainless Headed Compression Screw System Screws 4.0mm Full Thread Screws 4.5mm Full Thread Cannulated Screw 4.0, L 10, full thread Cannulated Screw 4.0, L 12, full thread Cannulated Screw 4.0, L 14, full thread Cannulated Screw 4.0, L 16, full thread Cannulated Screw 4.0, L 18, full thread Cannulated Screw 4.0, L 20, full thread Cannulated Screw 4.0, L 22, full thread Cannulated Screw 4.0, L 24, full thread Cannulated Screw 4.0, L 26, full thread Cannulated Screw 4.0, L 28, full thread Cannulated Screw 4.0, L 30, full thread Cannulated Screw 4.0, L 32, full thread Cannulated Screw 4.0, L 34, full thread Cannulated Screw 4.0, L 36, full thread Cannulated Screw 4.0, L 38, full thread Cannulated Screw 4.0, L 40, full thread Cannulated Screw 4.0, L 42, full thread Cannulated Screw 4.0, L 44, full thread Cannulated Screw 4.0, L 46, full thread Cannulated Screw 4.0, L 48, full thread Cannulated Screw 4.0, L 50, full thread Cannulated Screw 4.5, L 20, full thread Cannulated Screw 4.5, L 22, full thread Cannulated Screw 4.5, L 24, full thread Cannulated Screw 4.5, L 26, full thread Cannulated Screw 4.5, L 28, full thread Cannulated Screw 4.5, L 30, full thread Cannulated Screw 4.5, L 32, full thread Cannulated Screw 4.5, L 34, full thread Cannulated Screw 4.5, L 36, full thread Cannulated Screw 4.5, L 38, full thread Cannulated Screw 4.5, L 40, full thread Cannulated Screw 4.5, L 42, full thread Cannulated Screw 4.5, L 44, full thread Cannulated Screw 4.5, L 46, full thread Cannulated Screw 4.5, L 48, full thread Cannulated Screw 4.5, L 50, full thread Cannulated Screw 4.5, L 52, full thread Cannulated Screw 4.5, L 54, full thread Cannulated Screw 4.5, L 56, full thread Cannulated Screw 4.5, L 60, full thread Cannulated Screw 4.5, L 64, full thread Cannulated Screw 4.5, L 68, full thread Cannulated Screw 4.5, L 72, full thread Screws 4.0mm Short Thread Screws 4.5mm Short Thread Cannulated Screw 4.0, L 10, TL 5, short thread Cannulated Screw 4.0, L 12, TL 5, short thread Cannulated Screw 4.0, L 14, TL 5, short thread Cannulated Screw 4.0, L 16, TL 6, short thread Cannulated Screw 4.0, L 18, TL 7, short thread Cannulated Screw 4.0, L 20, TL 8, short thread Cannulated Screw 4.0, L 22, TL 9, short thread Cannulated Screw 4.0, L 24, TL 10, short thread Cannulated Screw 4.0, L 26, TL 12, short thread Cannulated Screw 4.0, L 28, TL 14, short thread Cannulated Screw 4.0, L 30, TL 14, short thread Cannulated Screw 4.0, L 32, TL 15, short thread Cannulated Screw 4.0, L 34, TL 15, short thread Cannulated Screw 4.0, L 36, TL 15, short thread Cannulated Screw 4.0, L 38, TL 16, short thread Cannulated Screw 4.0, L 40, TL 16, short thread Cannulated Screw 4.0, L 42, TL 16, short thread Cannulated Screw 4.0, L 44, TL 17, short thread Cannulated Screw 4.0, L 46, TL 17, short thread Cannulated Screw 4.0, L 48, TL 18, short thread Cannulated Screw 4.0, L 50, TL 18, short thread Cannulated Screw 4.5, L 20, TL 7, short thread Cannulated Screw 4.5, L 22, TL 7, short thread Cannulated Screw 4.5, L 24, TL 8, short thread Cannulated Screw 4.5, L 26, TL 9, short thread Cannulated Screw 4.5, L 28, TL 9, short thread Cannulated Screw 4.5, L 30, TL 10, short thread Cannulated Screw 4.5, L 32, TL 11, short thread Cannulated Screw 4.5, L 34, TL 11, short thread Cannulated Screw 4.5, L 36, TL 12, short thread Cannulated Screw 4.5, L 38, TL 13, short thread Cannulated Screw 4.5, L 40, TL 13, short thread Cannulated Screw 4.5, L 42, TL 14, short thread Cannulated Screw 4.5, L 44, TL 15, short thread Cannulated Screw 4.5, L 46, TL 15, short thread Cannulated Screw 4.5, L 48, TL 16, short thread Cannulated Screw 4.5, L 50, TL 16, short thread Cannulated Screw 4.5, L 52, TL 17, short thread Cannulated Screw 4.5, L 54, TL 18, short thread Cannulated Screw 4.5, L 56, TL 19, short thread Cannulated Screw 4.5, L 60, TL 20, short thread Cannulated Screw 4.5, L 64, TL 21, short thread Cannulated Screw 4.5, L 68, TL 23, short thread Cannulated Screw 4.5, L 72, TL 24, short thread 7

9 Implants Washer, I-ø4.5, O-ø8.0 Instruments Tissue protection sleeve CS Obturator CS Obturator CS Drill sleeve CS 4.0, I-ø Drill sleeve CS 4.0, I-ø Drill Sleeve CS 4.5, I-ø Drill sleeve CS 4.5, I-ø Screwdriver cannulated CS , hexagonal, ø2.5, quick coupling Screwdriver cannulated CS 4.5, hexagonal, ø2.5, quick coupling Countersink CS , quick coupling Parallel drill guide CS , basic device Drill guide insert, CS Drill guide insert CS Cleaning wire ø1.2, CS Cleaning wire ø1.6, CS Drill CS 4.0, ø2.5, L 130, quick coupling, single use Drill CS 4.5, ø3.0, L 130, quick coupling, single use Drill CS 4.0, ø4.0, L 130, quick coupling, single use Drill CS 4.5, ø4.5, L 130, quick coupling, single use Direct measuring device, L 150, CS , closed Screw forceps, self-holding K-wire with trocar point, ø1.2, L K-wire with trocar point and thread, ø1.6, L Staple for washers Ratcheting Handle with quick coupling Tray mm/4.5mm Stainless Headed Compression Screw Instrument Case - Complete mm/4.5mm Tray Lid mm/4.5mm Tray Base mm Screw Caddy mm Screw Caddy mm/4.5mm Instrument Insert Component Materials Screws: Stainless Steel 8

10 6.5mm/7.5mm Integra Stainless Headed Compression Screw System Screws 6.5mm Full Thread Screws 7.5mm Full Thread Cannulated screw 6.5, full thread, L Cannulated screw 6.5, full thread, L Cannulated screw 6.5, full thread, L Cannulated screw 6.5, full thread, L Cannulated screw 6.5, full thread, L Cannulated screw 6.5, full thread, L Cannulated screw 6.5, full thread, L Cannulated screw 6.5, full thread, L Cannulated screw 6.5, full thread, L Cannulated screw 6.5, full thread, L Cannulated screw 6.5, full thread, L Cannulated screw 6.5, full thread, L Cannulated screw 6.5, full thread, L Cannulated screw 6.5, full thread, L Cannulated screw 6.5, full thread, L Cannulated screw 6.5, full thread, L Cannulated screw 6.5, full thread, L Cannulated screw 6.5, full thread, L Cannulated screw 6.5, full thread, L Cannulated screw 7.5, full thread, L Cannulated screw 7.5, full thread, L Cannulated screw 7.5, full thread, L Cannulated screw 7.5, full thread, L Cannulated screw 7.5, full thread, L Cannulated screw 7.5, full thread, L Cannulated screw 7.5, full thread, L Cannulated screw 7.5, full thread, L Cannulated screw 7.5, full thread, L Cannulated screw 7.5, full thread, L Cannulated screw 7.5, full thread, L Cannulated screw 7.5, full thread, L Cannulated screw 7.5, full thread, L Cannulated screw 7.5, full thread, L Cannulated screw 7.5, full thread, L Cannulated screw 7.5, full thread, L Cannulated screw 7.5, full thread, L Cannulated screw 7.5, full thread, L Cannulated screw 7.5, full thread, L 120 Screws 6.5mm, TL32 Screws 7.5mm, TL Cannulated screw 6.5, TL 32, L Cannulated screw 6.5, TL 32, L Cannulated screw 6.5, TL 32, L Cannulated screw 6.5, TL 32, L Cannulated screw 6.5, TL 32, L Cannulated screw 6.5, TL 32, L Cannulated screw 6.5, TL 32, L Cannulated screw 6.5, TL 32, L Cannulated screw 6.5, TL 32, L Cannulated screw 6.5, TL 32, L Cannulated screw 6.5, TL 32, L Cannulated screw 6.5, TL 32, L Cannulated screw 6.5, TL 32, L Cannulated screw 6.5, TL 32, L Cannulated screw 6.5, TL 32, L Cannulated screw 6.5, TL 32, L 120 Screws 6.5mm, TL Cannulated screw 7.5, TL 32, L Cannulated screw 7.5, TL 32, L Cannulated screw 7.5, TL 32, L Cannulated screw 7.5, TL 32, L Cannulated screw 7.5, TL 32, L Cannulated screw 7.5, TL 32, L Cannulated screw 7.5, TL 32, L Cannulated screw 7.5, TL 32, L Cannulated screw 7.5, TL 32, L Cannulated screw 7.5, TL 32, L Cannulated screw 7.5, TL 32, L Cannulated screw 7.5, TL 32, L Cannulated screw 7.5, TL 32, L Cannulated screw 7.5, TL 32, L Cannulated screw 7.5, TL 32, L Cannulated screw 7.5, TL 32, L Cannulated screw 7.5, TL 32, L Cannulated screw 7.5, TL 32, L Cannulated screw 6.5, TL 16, L Cannulated screw 6.5, TL 16, L Cannulated screw 6.5, TL 16, L Cannulated screw 6.5, TL 16, L Cannulated screw 6.5, TL 16, L Cannulated screw 6.5, TL 16, L Cannulated screw 6.5, TL 16, L Cannulated screw 6.5, TL 16, L Cannulated screw 6.5, TL 16, L Cannulated screw 6.5, TL 16, L Cannulated screw 6.5, TL 16, L Cannulated screw 6.5, TL 16, L Cannulated screw 6.5, TL 16, L Cannulated screw 6.5, TL 16, L Cannulated screw 6.5, TL 16, L Cannulated screw 6.5, TL 16, L Cannulated screw 6.5, TL 16, L Cannulated screw 6.5, TL 16, L Cannulated screw 6.5, TL 16, L 120

11 Screws 7.5mm, TL16 Instruments Cannulated screw 7.5, TL 16, L Cannulated screw 7.5, TL 16, L Cannulated screw 7.5, TL 16, L Cannulated screw 7.5, TL 16, L Cannulated screw 7.5, TL 16, L Cannulated screw 7.5, TL 16, L Cannulated screw 7.5, TL 16, L Cannulated screw 7.5, TL 16, L Cannulated screw 7.5, TL 16, L Cannulated screw 7.5, TL 16, L Cannulated screw 7.5, TL 16, L Cannulated screw 7.5, TL 16, L Cannulated screw 7.5, TL 16, L Cannulated screw 7.5, TL 16, L Cannulated screw 7.5, TL 16, L Cannulated screw 7.5, TL 16, L Cannulated screw 7.5, TL 16, L Cannulated screw 7.5, TL 16, L Cannulated screw 7.5, TL 16, L Cannulated screw 7.5, TL 16, L Cannulated screw 7.5, TL 16, L Drill sleeve CS Drill sleeve CS Cleaning wire ø2.5, CS Cleaning wire ø3.0, CS Tissue protection sleeve CS 6.5/ Obturator CS Obturator CS Countersink CS 6.5/7.5, Hudson Screwdriver cannulated CS 6.5/7.5, hex ø5.0, Hudson Parallel guide for K-wires, CS 6.5/ Cannulated drill CS 6.5, ø4.4, L 220, Hudson, single use Cannulated drill CS 7.5, ø5.0, L 220, Hudson, single use Direct measuring device CS 6.5/7.5, closed Screw holding forceps K-wire ø2.5 mm, L K-wire ø3.0 mm, L Ratcheting Handle with Hudson Cannulated screwdriver CS 6.5/7.5, T-handle Implants Tray Washer I-ø8.6, O-ø13.0 Component Materials Screws: Stainless Steel mm/7.5mm Stainless Headed Compression Screw Instrument Case Complete mm/7.5mm Tray Lid mm/7.5mm Tray Base mm Screw Caddy mm Screw Caddy mm/7.5mm Insert mm/7.5mm Instrument Insert Stainless Headed Compression Screw Precautions Cannulated screws, washers and guide wires supplied non-sterile. Therefore, they must be cleaned and sterilized before use. These products are intended for single use only. Integra disclaims any re-use of the implants and of the guide wires for cannulated screws. Medical devices may be used only for the functions for which they have been designed. Stainless steel implants should not be combined with titanium implants because of possible galvanic corrosion which might result in implant failure. The implant promotes fracture healing through its fixating action. The implant is not designed to withstand continuous loading without osseous support and fracture healing. Medical devices designed for fracture fixation and subjected to fatigue cannot be expected to tolerate the same activities as normal healthy bone. Thus, the system for fracture healing is not as stable, resilient and resistant as normal human bone. Screwdrivers must always be fully inserted into the screw head and in line with the long axis of the screw. Before surgery, the surgeon must be well versed in the general surgical procedure and particularly in the surgical technique required for the medical devices used. Careful bone reconstruction and the correct choice and position of the implant are crucial, and after implantation correct placement must be checked. Preoperative planning is recommended for selecting proper implant size and position. Instructions on implant combinations are included in the description of the pertinent surgical technique. Since the system has not tested any combination of medical devices and instruments by other manufacturers, responsibility in this case rests solely with the surgeon. This screw system has not been evaluated for safety and compatibility in the MRI environment. This screw system has not been tested for heating or migration in the MRI environment. 10

12 Integra Stainless Headed Compression Screw System For more information or to place an order, please contact: Integra n 311 Enterprise Drive, Plainsboro, NJ USA n outside USA n fax integralife.com Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation Integra LifeSciences Corporation. All rights reserved. Printed in the USA

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