SHAFT FOR TREPHINE ATTACHMENTS

Additional Manufacturer Narrative

DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. ADDITIONAL NARRATIVE: D9: COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. E3: REPORTER IS A SYNTHES EMPLOYEE. H3, H6: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE. PART: 03.111.030-15. LOT: 8408P10. IT WAS ELECTRONICALLY REVIEWED AND NO NONCONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON: 25-JANUARY-2024 MANUFACTURING SITE: JABIL BETTLACH THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER PHOTOS WERE RECEIVED FOR REVIEW. THE PHOTO INVESTIGATION REVEALED THAT 03.111.030 (SHAFT F/TREPHINE+EXTRACTION ATTACHMENT) HAD BROKEN INTO TWO PIECES. THE OBSERVED CONDITION OF THE DEVICE WAS CONSISTENT WITH A COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCES. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE SHAFT F/TREPHINE+EXTRACTION ATTACHMENT WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, POTENTIAL CAUSE CAN BE ATTRIBUTED TO COMPONENT FAILURE AND 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 COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. AT THE TIME OF USING THE ORTHOPAEDIC FOOT INSTRUMENTS IT WAS REALISED THERE WERE NO GUIDE WIRES FOR TREPHINES ON THE SET. THE SALES REP CLARIFIED THAT THEY WERE STERILE AND PACKED SEPARATELY IN A SECOND PACKAGE. THEATRE STAFF WENT TO FIND THE PACKAGE. UPON RETURN, THE SURGEON HAD USED A 2.5MM K-WIRE FROM THE SET AND PROCEEDED TO USE THE BONE HARVESTER OVER IT. WHEN ATTEMPTING TO EXTRACT THE GRAFT, THE PRONGS ON THE SHAFT FOR TREPHINES BROKE AND CONSEQUENTLY THE TREPHINE REMAINED IN THE PATIENT. THERE WAS ABOUT A THIRTY MINUTE DELAY WHILE THE SURGEON REMOVED THE TREPHINE AND METAL FRAGMENTS. THE REST OF THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO FURTHER PROBLEMS WERE REPORTED. SURGEON WAS HAPPY WITH THE END RESULT. THIS REPORT IS FOR A SHAFT FOR TREPHINE ATTACHMENTS. THIS IS REPORT 1 OF 1 FOR (B)(4).