CSS Cannulated Screw System SURGICAL TECHNIQUE
Contents Chapter 1 4 Product Information 4 Device Description Chapter 2 5 Intended Use 5 Indications 5 Contraindications Chapter 3 6 Surgical Technique Appendix 11 Ordering Information Wright recognizes that proper surgical procedures and techniques are the responsibility of the medical professional. The following guidelines are furnished for information purposes only. Each surgeon must evaluate the appropriateness of the procedures based on his or her personal medical training, experience, and patient condition. Prior to use of the system, the surgeon should refer to the product Instructions For Use package insert (152231) for additional warnings, precautions, indications, contraindications and adverse effects. Instructions For Use package inserts are also available by contacting the manufacturer. Contact information can be found on the back of this surgical technique and the Instructions For Use package inserts are available on wmt.com under the link for Prescribing Information. Please contact your local Wright representative for product availability.
Product Information chapter 1 Device Description The CSS is a cannulated bone screw that consists of a threaded implant and corresponding instrumentation to facilitate insertion. The implants are cylindrical in shape and incorporate a center cannula designed for use with a guide wire to facilitate proper placement of the implant. An internal cruciate-head allows for maximal torque with minimal risk of stripping. These screws are all self-tapping. CSS Cannulated Screws Are Available In The Following Sizes 4 Chapter 1 Product Information
Intended Use chapter 2 Indications The CSS cannulated bone screw is indicated for bone fractures, osteotomies, arthodeses, osteochronditis and tendon reattachment. These screws are not intended for attachment or fixation to the posterior elements (pedicles) of cervical, thoracic, or lumbar spine. Contraindications The CSS cannulated bone screw is contraindicated for use in patients with the following conditions: Active local infection (any evidence of infection); Metal sensitivity or allergic reaction to foreign bodies; Poor or insufficient bone stock; The presence of any clinical or functional abnormalities that would; preclude the potential of achieving a good result for the patient; Other conditions that may place the patient at risk (physiologically). Prior to use of the system, the surgeon should refer to the product instructions for use package insert for warnings, precautions, indications, contraindications and adverse effects. Instructions for use package inserts are also available by contacting the manufacturer. Contact information can be found on the back of this surgical technique and the instructions for use package inserts are available on wmt.com under the link for Prescribing Information. Chapter 2 Intended Use 5
Surgical Technique chapter 3 An incision is made dorsally over the PIPJ. Then a transverse tenotomy and capsulotomy are performed at the PIP joint level. The medial and lateral collateral ligaments are transected. FIGURE 1 FIGURE 1 The articular cartilage and a small amount of bone are removed from the head of the proximal phalanx transversely using a sagital saw. FIGURE 2 FIGURE 2 6 Chapter 3 Surgical Technique
Then the articular cartilage and a small amount of bone are removed from the base of the intermediate phalanx. The joint is then approximated to ensure proper alignment and fit with the toe held in a rectus position appropriate for fusion. FIGURE 3 FIGURE 3 A.062 K-wire is then driven from proximal to distal, through the intermediate and distal phalanx, exiting the distal tip of the toe. This is used as an overdrill technique. FIGURE 4 FIGURE 4 Chapter 3 Surgical Technique 7
Next, a 0.9mm guide wire is used to freely pass through the distal and intermediate phalanx, then retrograded (from distal to proximal) through the proximal phalanx, stopping at the subchondral bone at the base of the proximal phalanx. FIGURE 5 NOTE: If a 2.5mm cannulated screw is to be used rather than a 2.0mm cannulated screw, use the 1.1mm guide wire with the same technique. FIGURE 5 Proper placement of the guide wire should be verified through image intensification via fluoroscopy. FIGURE 6 FIGURE 6 At this time a 3mm transverse/horizontal incision is made at the distal aspect of the toe to include the guide wire exit site. The cannulated countersink is then placed over the 0.9mm guide wire and used to remove a small amount of tissue and bone sparingly from the tip of the distal phalanx. FIGURE 7 FIGURE 7 8 Chapter 3 Surgical Technique
The cannulated depth gauge is then placed over the 0.9mm guide wire to determine the proper screw length. Surgeons should chose a screw length that avoids crossing into the MPJ, while having all threads proximal to the PIPJ fusion site. FIGURE 8 NOTE: The 2.0mm CSS cannulated screws range in 5mm lengths from 30mm to 50mm / the 2.5mm cannulated screws range in 2mm lengths from 30mm to 50mm. FIGURE 8 The 2.0mm or 2.5mm cannulated screw and coordinating cannulated screw driver are then placed over the guide wire. The screw is placed from the distal aspect of the digit crossing the DIPJ and PIPJ fusion site. FIGURE 9 FIGURE 9 Placement of the guide wire and screw should again be visualized through fluoroscopy. FIGURE 10 NOTE: One should note that rigid, end to end fixation of the two bones is accomplished. The head of the screw should be well below the distal tip of the toe and nonpalpable. FIGURE 10 Chapter 3 Surgical Technique 9
Attention can then be directed to the MPJ as needed. The guide wire may be retrograded across the MPJ for stability as needed. FIGURE 11 FIGURE 11 The guide wire is then bent and cut at the distal tip of the toe. Extensor tendon edges and capsule tissues are reapproximated and closed. Standard closure is then performed. FIGURE 12 FIGURE 12 Postoperative Protocol A postoperative shoe may be used for those patients that do not have fixation across the MPJ. Otherwise, they should be placed in a walking boot to protect the integrity of the MPJ positioning and hardware. Postoperative care is the responsibility of the medical professional. Explant Information If the removal of the implant is required due to revision or failure of the device, the surgeon should contact the manufacturer using the contact information located on the back cover of this surgical technique to receive instructions for returning the explanted device to the manufacturer for investigation. 10 Chapter 3 Surgical Technique
Headline Ordering Headline Information Appendix CSS Cannulated Screw System 3500KIT1/A 1 4 2 3 LEVEL 1 5 6 7 8 9 12 14 10 11 13 LEVEL 2 P/N Description 1. 03-400X-XX Cannulated Screws 2. 1040-4001-0.9 0.9mm CSS Guidewire 3. 1040-4001-1.1 1.1mm CSS Guidewire 4. 03-4000-08 Screw Pickups 5. 03-4000-02 Cannulated Depth Gauge 6. 03-4000-15 Silicone Handle 7. 03-4000-26 2.0mm Cannulated Screw Driver 8. 03-4000-24 2.5/3.0mm Cannulated Screw Driver 9. 03-4000-25 3.5/4.0mm Cannulated Screw Driver 10. 03-4000-13 Small Cannulated Countersink 11. 03-4000-14 Large Cannulated Countersink 12. 03-4000-18 2.0mm Cannulated Drill Bit 13. 03-4000-19 2.7mm Cannulated Drill Bit 14. 03-4000-03 Screw Measuring Block Appendix Ordering Information 11
PN Description 03-4001-08 Ø 2.0 x 8mm Cannulated Screw (Green) 03-4001-10 Ø 2.0 x 10mm Cannulated Screw (Green) 03-4001-12 Ø 2.0 x 12mm Cannulated Screw (Green) 03-4001-14 Ø 2.0 x 14mm Cannulated Screw (Green) 03-4001-16 Ø 2.0 x 16mm Cannulated Screw (Green) 03-4001-18 Ø 2.0 x 18mm Cannulated Screw (Green) 03-4001-20 Ø 2.0 x 20mm Cannulated Screw (Green) 03-4001-30 Ø 2.0 x 30mm Cannulated Screw (Green) 03-4001-35 Ø 2.0 x 35mm Cannulated Screw (Green) 03-4001-40 Ø 2.0 x 40mm Cannulated Screw (Green) 03-4001-45 Ø 2.0 x 45mm Cannulated Screw (Green) 03-4001-50 Ø 2.0 x 50mm Cannulated Screw (Green) PN Description 03-4002-10 Ø 2.5 x 10mm Cannulated Screw (Gold) 03-4002-12 Ø 2.5 x 12mm Cannulated Screw (Gold) 03-4002-14 Ø 2.5 x 14mm Cannulated Screw (Gold) 03-4002-16 Ø 2.5 x 16mm Cannulated Screw (Gold) 03-4002-18 Ø 2.5 x 18mm Cannulated Screw (Gold) 03-4002-20 Ø 2.5 x 20mm Cannulated Screw (Gold) 03-4002-22 Ø 2.5 x 22mm Cannulated Screw (Gold) 03-4002-24 Ø 2.5 x 24mm Cannulated Screw (Gold) 03-4002-26 Ø 2.5 x 26mm Cannulated Screw (Gold) 03-4002-28 Ø 2.5 x 28mm Cannulated Screw (Gold) 03-4002-30 Ø 2.5 x 30mm Cannulated Screw (Gold) 03-4002-32 Ø 2.5 x 32mm Cannulated Screw (Gold) 03-4002-34 Ø 2.5 x 34mm Cannulated Screw (Gold) 03-4002-36 Ø 2.5 x 36mm Cannulated Screw (Gold) 03-4002-38 Ø 2.5 x 38mm Cannulated Screw (Gold) 03-4002-40 Ø 2.5 x 40mm Cannulated Screw (Gold) 03-4002-42 Ø 2.5 x 42mm Cannulated Screw (Gold) 03-4002-44 Ø 2.5 x 44mm Cannulated Screw (Gold) 03-4002-46 Ø 2.5 x 46mm Cannulated Screw (Gold) 03-4002-48 Ø 2.5 x 48mm Cannulated Screw (Gold) 03-4002-50 Ø 2.5 x 50mm Cannulated Screw (Gold) 12 Appendix Ordering Information
PN Description 03-4003-12 Ø 3.0 x 12mm Cannulated Screw (Blue) 03-4003-14 Ø 3.0 x 14mm Cannulated Screw (Blue) 03-4003-16 Ø 3.0 x 16mm Cannulated Screw (Blue) 03-4003-18 Ø 3.0 x 18mm Cannulated Screw (Blue) 03-4003-20 Ø 3.0 x 20mm Cannulated Screw (Blue) 03-4003-22 Ø 3.0 x 22mm Cannulated Screw (Blue) 03-4003-24 Ø 3.0 x 24mm Cannulated Screw (Blue) 03-4003-26 Ø 3.0 x 26mm Cannulated Screw (Blue) 03-4003-28 Ø 3.0 x 28mm Cannulated Screw (Blue) 03-4003-30 Ø 3.0 x 30mm Cannulated Screw (Blue) 03-4003-32 Ø 3.0 x 32mm Cannulated Screw (Blue) 03-4003-34 Ø 3.0 x 34mm Cannulated Screw (Blue) 03-4003-36 Ø 3.0 x 36mm Cannulated Screw (Blue) 03-4003-38 Ø 3.0 x 38mm Cannulated Screw (Blue) 03-4003-40 Ø 3.0 x 40mm Cannulated Screw (Blue) 03-4003-42 Ø 3.0 x 42mm Cannulated Screw (Blue) 03-4003-44 Ø 3.0 x 44mm Cannulated Screw (Blue) 03-4003-46 Ø 3.0 x 46mm Cannulated Screw (Blue) 03-4003-48 Ø 3.0 x 48mm Cannulated Screw (Blue) 03-4003-50 Ø 3.0 x 50mm Cannulated Screw (Blue) PN Description 03-4004-12 Ø 3.5 x 12mm Cannulated Screw (Purple) 03-4004-14 Ø 3.5 x 14mm Cannulated Screw (Purple) 03-4004-16 Ø 3.5 x 16mm Cannulated Screw (Purple) 03-4004-18 Ø 3.5 x 18mm Cannulated Screw (Purple) 03-4004-20 Ø 3.5 x 20mm Cannulated Screw (Purple) 03-4004-22 Ø 3.5 x 22mm Cannulated Screw (Purple) 03-4004-24 Ø 3.5 x 24mm Cannulated Screw (Purple) 03-4004-26 Ø 3.5 x 26mm Cannulated Screw (Purple) 03-4004-28 Ø 3.5 x 28mm Cannulated Screw (Purple) 03-4004-30 Ø 3.5 x 30mm Cannulated Screw (Purple) 03-4004-32 Ø 3.5 x 32mm Cannulated Screw (Purple) 03-4004-34 Ø 3.5 x 34mm Cannulated Screw (Purple) 03-4004-36 Ø 3.5 x 36mm Cannulated Screw (Purple) 03-4004-38 Ø 3.5 x 38mm Cannulated Screw (Purple) 03-4004-40 Ø 3.5 x 40mm Cannulated Screw (Purple) 03-4004-42 Ø 3.5 x 42mm Cannulated Screw (Purple) 03-4004-44 Ø 3.5 x 44mm Cannulated Screw (Purple) 03-4004-46 Ø 3.5 x 46mm Cannulated Screw (Purple) 03-4004-48 Ø 3.5 x 48mm Cannulated Screw (Purple) 03-4004-50 Ø 3.5 x 50mm Cannulated Screw (Purple) Appendix Ordering Information 13
PN Description 03-4005-14 Ø 4.0 x 14mm Cannulated Screw (Bronze) 03-4005-16 Ø 4.0 x 16mm Cannulated Screw (Bronze) 03-4005-18 Ø 4.0 x 18mm Cannulated Screw (Bronze) 03-4005-20 Ø 4.0 x 20mm Cannulated Screw (Bronze) 03-4005-22 Ø 4.0 x 22mm Cannulated Screw (Bronze) 03-4005-24 Ø 4.0 x 24mm Cannulated Screw (Bronze) 03-4005-26 Ø 4.0 x 26mm Cannulated Screw (Bronze) 03-4005-28 Ø 4.0 x 28mm Cannulated Screw (Bronze) 03-4005-30 Ø 4.0 x 30mm Cannulated Screw (Bronze) 03-4005-32 Ø 4.0 x 32mm Cannulated Screw (Bronze) 03-4005-34 Ø 4.0 x 34mm Cannulated Screw (Bronze) 03-4005-36 Ø 4.0 x 36mm Cannulated Screw (Bronze) 03-4005-38 Ø 4.0 x 38mm Cannulated Screw (Bronze) 03-4005-40 Ø 4.0 x 40mm Cannulated Screw (Bronze) 03-4005-42 Ø 4.0 x 42mm Cannulated Screw (Bronze) 03-4005-44 Ø 4.0 x 44mm Cannulated Screw (Bronze) 03-4005-46 Ø 4.0 x 46mm Cannulated Screw (Bronze) 03-4005-48 Ø 4.0 x 48mm Cannulated Screw (Bronze) 03-4005-50 Ø 4.0 x 50mm Cannulated Screw (Bronze) 14 Appendix Ordering Information
Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 800 238 7117 901 867 9971 www.wmt.com Wright Medical EMEA Atlas Arena, Australia Building Hoogoorddreef 7 1101 BA Amsterdam the Netherlands 011 31 20 565 9060 Wright Medical UK Ltd. Unit 1, Campus Five Letchworth Garden City Hertfordshire SG6 2JF United Kingdom 011 44 (0)845 833 4435 Trademarks and Registered marks of Wright Medical Technology, Inc. 2014 Wright Medical Technology, Inc. All Rights Reserved. 011236A 06-Nov-2014