INTERLOCKING BOLT FOR 4.5MM VA-LCP CONDYLAR INSERTN HANDLE

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. D2B: ADDITIONAL DEVICE PRODUCT CODES: HRS, HWC. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. E3: REPORTER IS A J&J EMPLOYEE. H3, H4, H6: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 ON (B)(6) 2023, WHEN ASSEMBLING THE AIMING ARM TO ATTACH THE VA-LCP CURVED CONDYLAR PLATE, THE CONNECTING SCREW WAS NOT THREADING INTO THE HOLE IN THE PLATE TO ATTACH THE AIMING ARM. WHEN FURTHER EXAMINED, BOTH THE HOLE IN THE PLATE AND THE THREADED PART OF THE SCREW WERE DAMAGED. THE SURGEON HAD TO FREE HAND THE REST OF THE CASE WITHOUT THE AIMING ARM. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A 15-MINUTE DELAY. THIS REPORT INVOLVES ONE INTERLOCKING BOLT FOR 4.5MM VA-LCP CONDYLAR INSERTN HANDLE. THIS IS REPORT 2 OF 2 FOR (B)(4).