IDEAL SUTURE SHUTTLE 90 DEGREES

Additional Manufacturer Narrative

THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION SUMMARY: THE PRODUCT AND PHOTO WERE RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. J&J MEDTECH ORTHOPAEDICS THEN CONDUCTED VISUAL INSPECTION OF THE DEVICE RECEIVED. AFTER THE PHOTOS VISUALIZATION, IT WAS OBSERVED THAT THE IDEAL SUTURE SHUTTLE 90 DEGREES NEEDLE IS BROKE. THE REST OF THE VISIBLE PART OF THE DEVICE APPEARS TO BE IN A NORMAL CONDITION. VISUAL INSPECTION REVELED THAT THE NEEDLE IS BROKEN. THE REST OF THE DEVICE DOES NOT SHOW STRUCTURAL ANOMALIES. THE DEVICE WAS SENT TO THE MANUFACTURER FOR FURTHER INVESTIGATION. THE MANUFACTURER PERFORMED AN INVESTIGATION WITH THE FOLLOWING RESULTS: THE PROBLEM WAS CONFIRMED THE TIP WAS BROKEN. THE DEVICE RETURNED IS NOT IN FUNCTIONAL CONDITION. NO DIMENSIONAL ISSUES WERE DETECTED. ALL THE PROCESSES IN TAG FOR THE MANUFACTURE AND DESIGN OF THIS DEVICE ARE VALIDATED AND APPROVED. THE RECORD IN THE DHF COMPLIES WITH ALL REQUIREMENTS. IN THE INSTRUCTIONS FOR USE (IFU) IN THE PRECAUTIONS SECTION, IT IS SPECIFICALLY STATED THAT NO AXIAL OR BINDING FORCE TO BE APPLIED IN THE NEEDLE, THIS CAN CAUSE BREAKAGE. OUR INVESTIGATION TEAM CONCLUDED THAT THE IFU INSTRUCTION WERE NOT FOLLOWED AND THERE WAS A MISS USE OF THE DEVICE. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE IDEAL SUTURE SHUTTLE 90 DEGREES WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO MISUSE OF THE DEVICE. AS PER IFU; PRECAUTIONS; DO NOT APPLY EXCESSIVE AXIAL OR BENDING FORCES TO THE NEEDLE SHAFT OR SHUTTLE DURING USE, AS EXCESSIVE FORCE MAY LIMIT THE FUNCTION OF THE DEVICE OR CAUSE THE DEVICE TO BEND, DEFORM OR BREAK. CONTRAINDICATIONS: DO NOT USE THE IDEAL SUTURE SHUTTLE ON BONE OR OTHER SIMILARITY HARD. WARNINGS: WHETHER USED ARTHROSCOPICALLY OR IN OPEN SURGERY, THE IDEAL SUTURE SHUTTLE MUST BE USED UNDER DIRECT VISUALIZATION. INSTRUCTIONS FOR USE: READ THE INSTRUCTIONS FOR USE IN ITS ENTIRETY PRIOR TO USING THE DEVICE. 1. INSPECT THE IDEAL SUTURE SHUTTLE AND SHUTTLE PRIOR TO USE TO ENSURE PROPER MECHANICAL FUNCTION. 2. CHECK TO ENSURE PROPER FUNCTION BY DEPLOYING THE SHUTTLE LOOP THROUGH THE TIP OF THE INSTRUMENT SHAFT. 3. RETRACT THE SHUTTLE LOOP INTO THE NEEDLE TIP OF THE SHAFT (AT LEAST 5MM). THE IDEAL SUTURE SHUTTLE IS NOW READY FOR USE. LOADING THE IDEAL SUTURE SHUTTLE: 1. IF THE SHUTTLE NEEDS TO BE RE-LOADED INTO THE DEVICE: A. HOLD THE DEVICE SO THAT THE THUMB WHEEL IS FACING UPWARD. B. INSERT THE LOOP END OF THE SUTURE SHUTTLE INTO THE APERTURE DISTAL OF THE THUMB WHEEL. ADVANCE APPROXIMATELY 8-10CM OF THE SHUTTLE INTO THE HOLE. C. HOLD THE SHUTTLE FIRMLY BY PRESSING DOWN ON THE SHUTTLE ON TOP OF THE THUMB WHEEL. D. PULL THE REMAINDER OF THE SHUTTLE FIRMLY AND SLIDE THE LENGTH OF THE SHUTTLE ALONG THE HANDLE BELOW THE THUMB WHEEL INTO THE SHUTTLE LOADING SLOT, WHICH RUNS ON THE SIDE AND LENGTH OF THE HANDLE. E. PULL THE SHUTTLE FIRMLY SIDEWAYS INTO THE SHUTTLE LOADING SLOT UNTIL THE SHUTTLE ¿SNAPS¿ THROUGH THE SLOT WINDOW AND IS LOADED INTO THE HOLLOW HANDLE OF THE DEVICE. USE THE THUMB WHEEL TO ADVANCE THE SHUTTLE UNTIL THE LOOP END PROTRUDES OUT OF THE TIP OF THE NEEDLE. IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. H11 ADDITIONAL NARRATIVE: H4: THE DEVICE MANUFACTURE DATE WAS REPORTED AS UNKNOWN ON THE INITIAL REPORT. PLEASE NOTE THAT THE DATE OF MANUFACTURE HAS BEEN UPDATED ACCORDINGLY.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H11: ADDITIONAL NARRATIVE: D9, H3, H6: THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. E3: REPORTER IS A J&J SALES REPRESENTATIVE. H4: THE DEVICE MANUFACTURE DATE IS UNKNOWN. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED.

Description of Event or Problem

IT WAS REPORTED FROM JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) PROCEDURE, WHEN THE IDEAL SUTURE SHUTTLE 90 DEGREES SUTURING DEVICE WAS INSERTED INTO THE ROTATOR CUFF, THE TIP OF THE DEVICE WAS DISLODGED AND RETAINED IN THE BODY. IT WAS REPORTED THAT THE PROLAPSED TIP WAS REMOVED FROM THE PATIENT USING X-RAY. THE SURGEON CONFIRMED BY X-RAY THAT THERE WERE NO PIECES LEFT IN THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THERE WAS A 45-MINUTE SURGICAL DELAY AND THERE WAS NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.