The Ceterix NovoStitch Disposable Suture Passer Ceterix Orthopaedic cs 959 Hamilton Avenue Menlo Park, CA 94025 Customer Service: (650) 241 1748 IK D i Sterile Do Not Reusee See Instructions for Use THE CETERIX NOVOSTITCH DISPOSABLE SUTURE PASSER CAUTION: Federal law restricts this device to sale by or on the order of a physician. DESCRIPTION The Ceterix NovoStitch Disposable Suture Passer device is an arthroscopicc suture passer designed to pass USP size 2 0 or 0 braided surgical suture through soft tissue in arthroscopic surgery. The device has a diameter less than 6..5mm. The needle is retractable. INDICATION FOR USE The device is indicatedd for passing suture through soft tissue in orthopaedic surgery. CONTRAINDICATIONS The device is not to be used on bone or other hard tissue. P/N: LBL 0012 Rev: A Page 1
WARNINGS 1. Whether used arthroscopically or open surgery, the device must be used under direct visualization. 2. Do not force the device into tight joint spaces. Excessive pushing, twisting or levering may cause breakage. 3. Do not force the upper jaw open or closed. 4. Do not force the lower jaw into position. PRECAUTIONS This device should be used only by physicians with a thorough understanding of arthroscopic procedures. The device is provided STERILE for SINGLE USE ONLY. This product is for single use only. It has not been designed to be re used or re sterilized. Reprocessing may lead to changes in material characteristics such as corrosion and dulled edges, which may impact the strength of the device and compromise performance. Reprocessing of single use devices can also cause cross contamination leading to patient infections. These risks may potentially affect patient safety. PREPARATIONS FOR USE Read the Instructions for Use in its entirety prior to use of the device. Inspect the device prior to use to ensure proper mechanical function. Figure 1: The Ceterix NovoStitch Disposable Suture Passer Lever C Lower jaw retractor Radiused upper jaw Sliding lower jaw (retracted position) Lever A Upper jaw lever Lever B Lower jaw / needle lever 1 st squeeze advances lower jaw. Squeezing with advanced lower jaw drives the needle. Page 2
DIRECTIONS FOR USE PASSING SUTURE THROUGH MENISCAL TISSUE 1. Select USP size 2 0 or 0 braided suture and have available in the sterile field along with the device. CAUTION: Do NOT use suture other than braided USP size 2 0 or 0. 2. Suture Loading: Carefully follow these steps to ensure correct suture loading. a. Advance the lower jaw by holding the pistol grip (without Lever A) and squeezing Lever B until the lower jaw is fully advanced (see Figure 2). Figure 2: Fully advanced lower jaw. b. Load approximately 6 of one suture end into the lower jaw slot. Grab the short strand and the remaining suture, forming a loop around the left tine of the lower jaw. Pull the loop proximally (see Figure 3). Figure 3: Form a loop around the left tine of the lower jaw. Page 3
c. While maintaining proximal tension on the loop, slightly squeeze Lever B so that the needle moves forward about 1 mm (see Figure 4), then release Lever B. Do not fully advance Lever B at this stage. The suture strand will be locked in the lower jaw by the needle. Figure 4: Slightly squeeze Lever B to advance needle approximately 1mm. d. Retract the lower jaw by pushing down on Lever C (see Figure 1), the lower jaw retractor. e. The suture is now loaded for passing suture through soft tissue. 3. With the suture loaded and the lower jaw in the retracted position, pass the device into the surgical site under arthroscopic visualization. 4. Advance the upper jaw along the superior surface of the meniscus following the radius of the femoral condyle. 5. When the upper jaw is in position, fully advance the lower jaw by squeezing Lever B (see Figure 1 above) without squeezing Lever A, the upper jaw lever. Ensure that the lower jaw slides underneath the meniscus and release Lever B. 6. When both upper and lower jaws are in position, deploy the needle and suture limb by simultaneously squeezing Levers A and B (see Figure 1 above) until Lever B is fully advanced. The suture outside of the access port should be observed advancing in tandem with the needle trigger advancement. If the suture does not advance, or if the suture breaks, the suture may be pinched between the device and the surrounding structures. If this occurs, consider adjusting the patient position before redeploying the needle. 7. Release both Levers A and B and then retract the lower jaw by pushing down Lever C. Carefully remove the device from the joint. Remove the suture end from the upper jaw by pulling in the proximal direction. Page 4
8. If needed, repeat steps 2 through 7 using the opposing suture end. This will create a circumferential stitch. 9. Using standard surgical techniques and a commercially available knot pusher, advance a knot to the surface of the tissue until tissue approximation at the tear is observed. Place the appropriate number of additional throws to ensure that the knot is secure. 10. Using a commercially available arthroscopic suture cutter, trim the suture limbs from the knot. 11. Bench deployment testing has demonstrated that the device can be reloaded with suture and fully actuated 14 times. Cycling the device in excess of 14 deployments may impact needle integrity and compromise performance. 12. Immediately discard the Ceterix NovoStitch Disposable Suture Passer after completion of the surgery. The device is SINGLE USE ONLY. STORAGE Store in a cool, dry area. Page 5