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. H11 ADDITIONAL NARRATIVE: E3: REPORTER IS A J&J SALES REPRESENTATIVE. 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 CHINA THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE IDEAL SUTURE SHUTTLE 90 DEGREES DEVICE WAS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE 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 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 A PHOTO WERE RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED PHOTO SHOW THE DEVICE OVER ITS OUTER BOX, THE NEEDLE DOES NOT APPEAR TO HAVE STRUCTURAL ANOMALIES, NO BROKEN AREAS WERE DETECTED, HOWEVER A SCRATCH CAN BE OBSERVED AT THE TOP OF THE HANDLE. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THE DEVICE IS IN USED CONDITION. THE NITINOL WIRE IS BROKEN, ALSO THE HANDLE IS SCRATCHED. NO OTHER ANOMALIES WERE NOTED. THE DEVICE WAS SENT TO THE SUPPLIER FOR FURTHER EVALUATION. THE SUPPLIER PERFORMED AN EVALUATION WITH THE FOLLOWING RESULTS: DEVICE IS IN GOOD COSMETIC CONDITION. DEVICE NOT FUNCTIONAL-WIRE LOOP IS BROKEN. DEVICE MEETS ALL DIMENSIONAL REQUIREMENTS. OUR INVESTIGATION TEAM PERFORMED THE INVESTIGATION. 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. ALSO NOTE THAT THERE IS NO RECORD OF DISCREPANCY RECORDED IN THE DHF. THIS DEVICE WAS INSPECTED AND APPROVED BY CERTIFIED INSPECTORS. THE RETURNED DEVICE HAS A BROKEN NITINOL LOOP. OUR INVESTIGATION TEAM AFTER REVIEWING THE ABOVE INFORMATION, CONCLUDED THAT END USER DID NOT FOLLOW ALL THE INSTRUCTIONS FOR USE (IFU) INSTRUCTIONS AND PRECAUTION. 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 PROCEDURAL VARIABLES SUCH AS; HANDLING OF THE DEVICE OR PRODUCT INTERACTION DURING PROCEDURE; AN EXCESSIVE MANIPULATION OF THE DEVICE CAUSED THE WIRE TO BREAK. AS PER IFU, 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. A DAMAGED OR BROKEN DEVICE MAY RESULT IN EXTENDED OR ADDITIONAL SURGERIES OR RESIDUAL FOREIGN BODIES. 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 LOT: 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. D9, H3, H6: THE ACTUAL DEVICE AND A PHOTO HAVE BEEN RETURNED AND ARE CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.