IDEAL SUTURE SHUTTLE 90 DEGREES

Description of Event or Problem

IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS FOUND THAT THE IDEAL SUTURE SHUTTLE 90 DEGREES DEVICE HAD INSUFFICIENT MATERIAL HARDNESS, MAKING THE TIP EASILY BENDABLE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

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: E1: THE REPORTER¿S COMPLETE FACILITY ADDRESS WAS NOT PROVIDED. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED.

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: INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THE DEVICE WAS RETURNED IN USED CONDITION, A SLIGHT DEFORMATION COULD BE OBSERVED ON THE DEVICE, HOWEVER THE DEVICE CONDITION DID NOT CORRESPOND TO THE PHOTO PREVIOUSLY PROVIDED. IT IS POSSIBLE THAT DURING THE SAMPLE TRANSPORT, THE DEVICE TIP COULD HAVE CHANGED THE DEFORMATION DEGREE. NO OTHER ANOMALIES WERE NOTED. THE MANUFACTURER PERFORMED AN INVESTIGATION BASED ON THE PHOTO PREVIOUSLY PROVIDED WITH THE FOLLOWING RESULTS: THE INVESTIGATION WAS CONDUCTED BY A CROSS-FUNCTIONAL TEAM COMPRISING REPRESENTATIVES FROM ENGINEERING, PRODUCTION, QUALITY CONTROL AND QUALITY ASSURANCE. THE FINDINGS PRESENTED REFLECT THEIR COLLECTIVE ASSESSMENT. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO DISCREPANCIES WERE IDENTIFIED. ALL IN-PROCESS AND FINAL INSPECTIONS WERE CONDUCTED IN ACCORDANCE WITH THE DEVICE MASTER RECORD (DMR) REQUIREMENTS. NO DEVIATIONS WERE OBSERVED OR RECORDED IN THE DHR. ALL DMR-REQUIRED STEPS AND SPECIFICATIONS WERE FOLLOWED, EXECUTED, AND APPROPRIATELY SIGNED OFF. ALL MANUFACTURING AND DESIGN PROCESSES AT TAG FOR THIS DEVICE ARE FULLY VALIDATED AND APPROVED. THERE IS NO REMAINING INVENTORY OF LOT 24J07 AT TAG. THE INSTRUCTIONS FOR USE (IFU) STATES WITH THE NECESSARY INFORMATION PROVIDED FOR THE USE OF THIS DEVICE. THE DEVICE CLEARLY STATES THAT THE SUTURE SHUTTLE IS INTENDED BE USED ONLY FOR PASSING SUTURE THROUGH TISSUES. IN THE CONTRADICTION SECTION, IT EXPLICITLY WARNS NOT TO USE THE DEVICE ON BONE OR OTHER SIMILAR HARD TISSUES. ADDITIONALLY, THE PRECAUTIONS SECTIONS EMPHASIZE THAT EXCESSIVE FORCE MAY COMPROMISE THE DEVICE¿S FUNCTION, POTENTIALLY CAUSING IT TO BEND, DEFORM OR BREAK. THE INSTRUCTIONS FOR USE PROVIDED DETAILED GUIDANCE TO ENSURE THE DEVICE IS USED CORRECTLY AND WITHIN ITS INTENDED CLINICAL APPLICATION. FOLLOWING A THOROUGH REVIEW OF THE COMPLAINT DESCRIPTION, IFU REQUIREMENTS AND PHOTOGRAPHIC EVIDENCE OF THE DEVICE IN QUESTION, OUR INVESTIGATION TEAM HAS CONCLUDED THAT THE COMPLAINT IS NON-JUSTIFIED. THE ISSUE APPEARS TO HAVE ARISEN FROM MISUSE DUE TO FAILURE TO ADHERE TO THE IFU INSTRUCTIONS. ROOT CAUSE: IFU INSTRUCTIONS NOT FOLLOWED, CAUSE MISUSE 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. A PHOTO WAS PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED PHOTO FOUND THAT THE DEVICE TIP WAS DEFORMED. NO OTHER ANOMALIES WERE NOTED. BASED ON THE INVESTIGATION FINDINGS, A POTENTIAL CAUSE COULD BE TRACED TO USE. 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.