IDEAL SUTURE SHUTTLE 45 DEGREES LEFT

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 DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY 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. D9, H3, H6: THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY. B5: DURING FURTHER INVESTIGATION WITH THE CUSTOMER IT WAS REPORTED BY THE NURSE THAT IMMEDIATELY AFTER OPENING THE PRODUCT, THE WIRE MOVEMENT WAS NOT GOOD AND COULD NOT BE USED. ACCORDING TO THE REPORTER, THEY COULD NOT USE THE PRODUCT BECAUSE THE MOVEMENT OF THE ROLLER PART WAS NOT GOOD AND THE WIRE DID NOT MOVE.

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 DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY 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: 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 BY THE SALES REP IN JAPAN THAT DURING AN ARTHROSCOPIC SHOULDER LABIAPLASTY SURGICAL PROCEDURE ON THE SHOULDER JOINT TO TREAT A DISLOCATED SHOULDER ON (B)(6) 2024 THE IDEAL SUTURE SHUTTLE 45 DEGREES LEFT DEVICE DID NOT COME OUT PROPERLY AND COULD NOT BE USED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A THIRTY MINUTE DELAY IN THE PROCEDURE WAS REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

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 DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY 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: THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THE DEVICE COMES IN USED CONDITION. THE HANDLE AND SHAFT ARE IN GOOD CONDITION, NO STRUCTURAL ANOMALIES WERE FOUND. WHEN REVIEWING THE NEEDLE TIP, IT WAS FOUND THAT IS BENT AND THE NITINOL WIRE CANNOT BE PASSED TROUGH THE NEEDLE. THE DEVICE WILL BE SENT TO THE MANUFACTURER FOR FURTHER REVIEW. MANUFACTURER EVALUATION RESULT FOR IDEAL SUTURE SHUTTLE 45 DEGREES LEFT: THE DEVICE WAS CHECKED, THE TIP IS BENT. NO CORRECTIONS ARE REQUIRED, SINCE THE DEVICE WILL BE DISCARDED. PROBLEM CONFIRMED: YES, THE TIP WAS BENT AND THE NITINOL WAS OUT. OUR INVESTIGATION TEAM, WHICH CONSISTS OF ENGINEERING, PRODUCTION, QC AND QA PERSONALS PERFORMED THE INVESTIGATION AND THIS IS THEIR FINDING. SEE IFU FOR INSTRUCTIONS ON THE USE OF THESE DEVICES. ACCORDING TO THE IFU INSTRUCTIONS AXIAL FORCE MUST NOT BE APPLIED ON THE SUTURE SHUTTLE. IN THE PRECAUTIONS IN THE IFU SAYS DO NOT APPLY AXIAL OR BENDING FORCES TO THE NEEDLE SHAFT. THE DESCRIPTION OF THIS DEVICE IT IS CLEARLY STATED THAT THE SUTURE SHUTTLE IS TO BE USED ONLY FOR PASSING SUTURE THROUGH TISSUES. IN THE CONTRADICTION SECTION ALSO WARNS NOT TO USE BONE OR OTHER SIMILAR TISSUES. THE INSTRUCTION FOR USE GUIDES THE RIGHT WAY OF USING THE DEVICE. IN ALL THE ABOVE INSTRUCTIONS THE DEVICE MUST BE USED WITH CARE AND TO FOLLOW THE INSTRUCTIONS. THIS DEVICE AND THE MANUFACTURING PROCESSES HAVE BEEN VALIDATED AND APPROVED. AS TO OUR RISK ANALYSIS REPORT, THE BENDING OF THE DEVICE HAS LITTLE POTENTIAL OF INJURY. AFTER REVIEWING ALL THE ABOVE INFORMATION, THE DESCRIPTION OF THE COMPLAINT AND THE INFORMATION IN THE IFU, OUR INVESTIGATION TEAM CONCLUDED THERE WAS A MISUSE OF THE DEVICE THAT CAUSED THIS FAILURE. ROOT CAUSE: MISUSE OF THE DEVICE. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE IDEAL SUTURE SHUTTLE 45 DEGREES LEFT WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO MISUSE OF THE DEVICE. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE, AND NO NON-CONFORMANCES WERE IDENTIFIED. D4: LOT NUMBER, EXPIRATION DATE AND UDI NUMBER, H4; ADDED.

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 DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY 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. D4: THE LOT NUMBER HAS BEEN ADDED..