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Asnis Micro Cannulated Screw System Operative Technique 2.0mm &.0mm Table of Contents 1. Introduction 2. Features & Benefits. Examples of Applications & Relative Contraindications 5 5. Operative Technique
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Asnis Micro Cannulated Screw System Operative Technique 2.0mm &.0mm Table of Contents 1. Introduction 2. Features & Benefits. Examples of Applications & Relative Contraindications 5 5. Operative Technique 5.1 Asnis Micro General Considerations Austin/Chevron Osteotomy Extraction Ordering Information 16 This Operative Technique sets forth detailed recommended procedures for using Stryker Osteosynthesis devices and instruments. It offers guidance that should be followed, but, as with any technical guide, each surgeon must consider the particular needs of each patient and make appropriate adjustments as required. The bone screws referenced in this Operative Technique are not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine. 2 Introduction Cannulated Screws have a long, proven clinical history in Orthopaedic surgery. Along with the arthroscope and image intensifier, cannulated screws have been a major facilitator of minimally invasive surgery. Extensive surgical exposure of bone fragments and intensive soft tissue stripping have been changed to a minimally invasive percutaneous procedure. The Asnis Micro 2.0mm and.0mm cannulated titanium screws dedicated for foot and hand surgery offer an effective solution for trauma and reconstructive indications. The Asnis Micro System is designed to facilitate surgical procedures by simplifying screw placement, insertion and removal. Small screw diameters, with low profile screw heads and the advanced cutting characteristics of the Asnis Micro Cannulated Screws are combined to meet the surgeons' needs in their daily practice. These important features make the Asnis Micro the system of choice. Features and Benefits Low Profile Screw Heads specially designed for reduced potential of soft tissue irritation 2.0mm and.0mm Diameters developed to meet the special needs of foot and hand surgeons Type III Anodization implants with Colour Coding for better distinction in the O.R. Reverse Cutting Flutes to facilitate implant removal Equal Shaft and Core Diameters developed for minimization of stress risers Self Cutting Screw Design with an efficient cutting tip to improve insertion properties Applications & Contraindications The Asnis Micro 2.0mm and.0mm Cannulated Screws are designed for fixation of fracture fragments, intra-articular fractures and fixation of osteotomy sites in the hand and foot. The physician s education, training and professional judgement must be relied upon to choose the most appropriate device and treatment option. Examples of Applications Relative Contraindications Fractures of the Phalanges, Metatarsals, Tarsals and Ankle Fractures of the Phalanges, Metacarpals, Carpals and Distal Radius Fractures of the Patella Corrective Osteotomies of the Fore-, Mid- and Hind Foot and the Hand Arthrodeses in the Fore-, Mid- and Hind Foot Ligament Fixation Compromised vascularity that would inhibit adequate blood supply to the fracture on the operative site Any active or suspect latent infection or marked local inflammation in or about the affected area Material sensitivity documented or suspected Patients having inadequate tissue coverage over the operative site Bone stock compromised by diseases, infection or prior implantation that can not provide adequate support and/or fixation Implant utilization that would interfere with anatomical structures or physiological performance An overweight or obese patient can produce loads on the implant which can lead to failure of the fixation or to failure of the device itself Any mental or neuromuscular disorder which could create an unacceptable risk of fixation failure or complications in postoperative care Other medical or surgical conditions which would preclude the potential benefit of the surgery. For additional information please refer to the Instructions For Use (IFU), Ref.-No delivered with each implant and IFU, Ref.- No delivered with each instrument. 5 Operative Technique Asnis Micro General Considerations Guide Wire Insertion Insert the K-Wire using the Double Drill Guide at the entry point of the final screw placement to the appropriate depth. In case of dense cortical or pediatric bone, puncture the proximal cortex before inserting the K-Wire, by using the solid drill bit manually or by power according to the screw diameter chosen. Countersinking of the Screw Head (Optional Step) Where soft tissue coverage is minimal, the option for countersinking the screw head for further recess of the low profile screw head may be used. Assemble the Elastosil Handle with the Cannulated Countersink by pushing the sleeve toward the tip, inserting the Countersink Head and releasing the sleeve. To disassemble the Cannulated Countersink push the sleeve forward and remove the tip. Apply the Countersink over the K-Wire and prepare the bone for countersinking by turning the instrument clockwise. Countersinking should be applied before screw length measurement since it influences the measurement of the overall screw length. Washers In osteoporotic bone or where the cortex is thin, Washers may be placed under the screw head in order to spread the load over a bigger area. After countersinking Washers cannot be used. 6 Operative Technique Asnis Micro General Considerations Measurement of the Screw Length All screw measurements need to be taken prior to drilling and/ or tapping over the K-Wire. In order to achieve the correct screw length measurement, ensure the final position of the K-Wire by using an image intensifier, or visually verify K-wire placement, prior to measurement. If countersinking is required, measurement of the screw length must be performed after using the countersink. Please note: After using any cannulated instrument over a K-Wire, make certain that the K-Wire did not shift or dislocate. Slide the Direct Measuring Gauge over the K-Wire and position it in direct contact with the bone. The Direct Measurement Gauge measures directly to the tip of the K-Wire, thus ensuring that the final screw position corresponds with the initial tip position of the K-Wire. The end of the K-Wire, when placed against the Direct Measurement Gauge, allows for a direct reading of the complete screw length to be used. This measurement includes the screw head. Subtract appropriately for any anticipated fracture reduction or inter-fragmentary reduction due to compression of the screw during insertion. The following can influence the result of your screw length measurement: If the measuring gauge is not placed perpendicular to the bone surface, the measurement can be influenced by up to 1 2mm During screw insertion into bone of poor quality, the screw head may sink into the bone, which can result in an unanticipated countersinking of approximately 1 2mm Due to the factors listed above, and to avoid penetration or damage of the articular surface, it is recommended to subtract a minimum of 1 2mm from the screw measurement, or as appropriate. Also note, when Washers are used, the height of the implanted washer (0. for the 2.0mm Asnis Micro Washer or 0.7mm for.0mm Asnis Micro Washer) needs to be considered for the overall screw length. After screw insertion always confirm proper screw length by using an image intensifier or through direct visual verification. 7 Operative Technique Asnis Micro General Considerations Pre-Drilling (Optional Step) In case of hard cortical or pediatric bone, pre-drilling can be used. Insert the Cannulated Drill Bit according to the screw diameter into a power or manual cannulated drill. Slide it over the K-Wire and overdrill the K-Wire to its tip by using the Double Drill Guide. Optionally the Solid Drill may be used without the use of a K-Wire. In order to avoid damaging the K-Wire use low speed or a manual drill. Screw Insertion Set Up Assemble the Cannulated Screwdriver onto the Elastosil Handle as described for the Cannulated Countersink on page 6. Take the Holding Sleeve and slide it over the Cannulated Screwdriver until it engages. Pull the sleeve toward the handle so that the tip of the screwdriver is visible. Place the screwdriver into the chosen screw, push the sleeve forward and take the screw securely out of the rack. Optionally screws may also be taken from the screw rack by using the Screw Foreceps. 8 Operative Technique Asnis Micro General Considerations Screw Insertion To prepare for insertion place the screw over the K-Wire onto the bone and draw the Holding Sleeve towards the handle, so that the screw head is visible. Insert the screw over the K-Wire by turning the screwdriver clockwise. After final insertion remove the screwdriver from the screw and verify the K-Wire and screw position with the image intensifier. After the positions have been verified remove and discard the K-Wire. To remove the Holding Sleeve compress the bushing. The entire Holding Sleeve can now be removed from the Screw Driver. 9 Operative Technique Austin / Chevron Osteotomy Bone Preparation Make a dorsal medial skin incision crossing the first Metatarsal Phalangeal Joint. Retract the soft tissues carefully, being certain to protect the neuro vascular bundle in the skin flap. Perform a lateral release if necessary through the same incision. This would include the release of the adductor tendon and the fibular sesamoidal ligament. Be aware of the superficial branch of the deep peroneal nerve. Perform a t-shaped incision of the capsule thus exposing the joint. Resect the medial eminence, with protection of the sagittal groove. 10 Operative Technique Austin / Chevron Osteotomy Osteotomy Insert the K-Wire in the center of the metatarsal head depending on the required osteotomy. Perform a V-shaped osteotomy at the head-neck level at an angle of 60, with the apex at the K-Wire. The head will follow the direction which is predetermined by the K-Wire placement. 60 Translate the capital fragment laterally. 11 Operative Technique Austin / Chevron Osteotomy Guide Wire Insertion Place the K-Wire for the screw in the appropriate position aiming at the center of the metatarsal head. Insert the K-Wire through the metatarsal head until the tip is visible and then retract it slightly so that the tip is below the level of articular cartilage. In case of dense cortical bone, puncture the cortex before inserting the K-Wire, by using the drill bit manually or by power according to the screw diameter chosen. Countersink of the Screw Head (Optional Step) Where soft tissue coverage is minimal, countersinking may be considered. Assemble the Cannulated Countersink by pushing the sleeve toward the tip, inserting the Cannulated Countersink and releasing the sleeve. Apply the Countersink over the K-Wire and prepare the bone for countersinking by turning the instrument clockwise Countersinking should be applied before screw length measurement since it influences the measurement of the overall screw length. Washers In osteoporotic bone or where the cortex is thin, Washers may be placed under the screw head in order to spread the load over a bigger area. After countersinking Washers cannot be used. 12 Operative Technique Austin / Chevron Osteotomy Measurement of the Screw Length All screw measurements need to be taken prior to drilling and/ or tapping over the K-Wire. In order to achieve the correct screw length measurement, ensure the final position of the K-Wire by using an image intensifier, or visually verify K-wire placement, prior to measurement. If countersinking is required, measurement of the screw length must be performed after using the countersink. Please note: After using any cannulated instrument over a K-Wire, make certain that the K-Wire did not shift or dislocate. Slide the Direct Measuring Gauge over the K-Wire and position it in direct contact with the bone. The Direct Measurement Gauge measures directly to the tip of the K-Wire, thus ensuring that the final screw position corresponds with the initial tip position of the K-Wire. The end of the K-Wire, when placed against the Direct Measurement Gauge, allows for a direct reading of the complete screw length to be used. This measurement includes the screw head. Subtract appropriately for any anticipated fracture reduction or inter-fragmentary reduction due to compression of the screw during insertion. The following can influence the result of your screw length measurement: If the measuring gauge is not placed perpendicular to the bone surface, the measurement can be influenced by up to 1 2mm During screw insertion into bone of poor quality, the screw head may sink into the bone, which can result in an unanticipated countersinking of approximately 1 2mm Due to the factors listed above, and to avoid penetration or damage of the articular surface, it is recommended to subtract a minimum of 1 2mm from the screw measurement, or as appropriate. Also note, when Washers are used, the height of the implanted washer (0. for the 2.0mm Asnis Micro Washer or 0.7mm for.0mm Asnis Micro Washer) needs to be considered for the overall screw length. After screw insertion always confirm proper screw length by using an image intensifier or through direct visual verification. 1 Operative Technique Austin / Chevron Osteotomy Pre-Drilling (Optional Step) In case of hard cortical bone, pre-drilling can be used. Insert the cannulated drill bit according to the screw diameter into a power or manual cannulated drill. Slide it over the K-Wire and overdrill the K-Wire to its tip by using the Double Drill Guide. Optionally the Solid Drill may be used without the use of a K-Wire. In order to avoid damaging the K- Wire use low speed or a manual drill. Screw Insertion Set Up Assemble the Cannulated Screwdriver onto the Elastosil Handle as described for the Cannulated Countersink on page 6. Take the Holding Sleeve and slide it over the Cannulated Screwdriver until it engages. Pull the sleeve towards the handle so that the tip of the screwdriver is visible. Place the screwdriver into the chosen screw, push the sleeve forward and take the screw securely out of the rack. 1 Operative Technique Austin / Chevron Osteotomy Screw Insertion To prepare for insertion, place the screw over the K-Wire onto the bone and draw the Holding Sleeve towards the handle so that the screw head is visible. Insert the screw over the K-Wire by turning the instrument clockwise. After final insertion remove the screwdriver from the screw and verify the K-Wire and screw position with the image intensifier. After the positions have been verified remove and discard the K-Wire. Resect the remaining head and neck prominence in a parallel plane to the medial border of the foot. Extraction Holding Sleeve Support In case of difficult screw extraction due to bone quality, the Holding Sleeve in combination with the Solid Screwdriver can be used as a support for lifting and turning the screw. 15 Ordering Information Implants Unsterile 2.0mm Asnis Micro Cannulated Screws REF Total Thread Recommended Length Length Set Item.0mm Asnis Micro Cannulated Screws REF Total Thread Recommended Length Length Set Item mm Asnis Micro Washer REF mm Asnis Micro Washer REF mm 20mm 22mm 22mm mm 11mm 1mm 1 17mm 17mm mm 7mm mm 20mm 22mm 22mm mm 2mm 0mm 11mm 1mm mm 17mm mm 21mm 2mm 2mm mm 27mm 2 2 0mm 2mm 0mm mm 7mm 7mm 7mm Recommended Set Item 16 Ordering Information Implants Sterile 2.0mm Asnis Micro Cannulated Screws, Sterile REF Total Thread Length Length.0mm Asnis Micro Cannulated Screws, Sterile REF Total Thread Length Length S S S S S S S S S S S S S S S S S S S S S S S S S S S mm 20mm 22mm 22mm mm 11mm 1mm 1 17mm 17mm mm 2.0mm Asnis Micro Washer, Sterile REF S.0mm Asnis Micro Washer, Sterile REF S 7mm S S 0-011S S S S S S S S 0-012S 0-022S S S S S 0-020S 0-022S 0-02S 0-026S 0-028S 0-020S S S S 0-011S 0-021S S S S S S S S S S 0-012S 0-022S S S S S S S 0-010S 0-012S 0-01S 0-016S 0-018S 0-010S mm 20mm 22mm 22mm mm 2mm 0mm 11mm 1mm mm 17mm mm 21mm 2mm 2mm mm 27mm 2 2 0mm 2mm 0mm mm 7mm 7mm 7mm Recommended Set Item 17 Ordering Information Instruments REF Description 2.0mm Asnis Micro Instruments S S S S S S S Cannulated Screwdriver 2.0 mm, AO Coupling Cannulated Screwdriver 2.0mm, AO Coupling, Sterile Solid Screwdriver, 2.0mm, AO Coupling Solid Screwdriver 2.0mm, AO Coupling, Sterile Cannulated Drill 1.7mm, AO Coupling, Single Use, Sterile Solid Drill 1.7mm, AO Coupling Solid Drill 1.7mm, AO Coupling, Sterile Cannulated Tap 2.0 mm, AO Coupling, Single Use, Sterile Cannulated Countersink 2., AO Coupling, Single Use, Sterile Holding Sleeve for 2.0mm Screws Double Drill Guide 0.8/1.7mm Cleaning Stylet 0. K-Wire 0.8 mm x 100 mm, Single Use K-Wire 0.8 mm x 100 mm, Single Use, Sterile.0mm Asnis Micro Instruments S S S S S S S Cannulated Screwdriver.0 mm, AO Coupling Cannulated Screwdriver.0mm, AO Coupling, Sterile Solid Screwdriver.0mm, AO Coupling Solid Screwdriver.0mm, AO Coupling, Sterile Cannulated Drill 2.1mm, AO Coupling, Single Use, Sterile Solid Drill 2.1mm, AO Coupling Solid Drill 2.1mm, AO Coupling, Sterile Cannulated Tap.0 mm, AO Coupling, Single Use, Sterile Cannulated Countersink., AO Coupling, Single Use, Sterile Holding Sleeve for.0 mm Screws Double Drill Guide 1.2/2.1mm Cleaning Stylet 1.2mm K-Wire 1.2 mm x 100 mm, Single Use K-Wire 1.2 mm x 100 mm, Single Use, Sterile 18 Ordering Information Instruments REF Description Asnis Micro Generic Instruments Asnis Micro, Direct Measuring Gauge 0.8/1.2 mm Asnis Micro Elastosil Handle, Cannulated, AO Coupling Screw Forceps Instrument Tray for Asnis Micro 2.0 and.0 System Screw Rack for Asnis Micro 2.0mm/.0mm Screws (including Lid) Container Stryker Foot Solutions ( Levels without Lid) Lid for Asnis Micro 2.0 and.0 System (Container Lid) Spare Parts Spring for 2.0mm and.0mm Holding Sleeve Lid for Asnis Micro Screw Rack 19 Trauma, Extremities & Deformities Biologics Surgical Products Neuro & ENT Stryker Leibinger GmbH & Co. KG Bötzinger Strasse 9-1 D Freiburg Germany The information presented in this brochure is intended to demonstrate a Stryker product. Always refer to the package insert, product label and/or user instructions before using any Stryker product. Surgeons must always rely on their own clinical judgment when deciding which products and techniques to use with their patients. Products may not be available in all markets. Product availability is subject to the regulatory or medical practices that govern individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area. Stryker Corporation or its subsidiary owns the registered trademark: Stryker Stryker Corporation or its subsidiary owns, uses or has applied for the following trademarks: Asnis Micro Wacker-Chemie GmbH owns the following trademark: Elastosil Literature Number : LOT C2608 Copyright 2008 Stryker
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