4.5 VA-LCP CRVD COND PL/14HOLE/301/RT-S

Description of Event or Problem

IT WAS REPORTED THAT ON APRIL 4, 2022, A HARDWARE REMOVAL OF A RETROGRADE FEMORAL NAIL -ADVANCED SYSTEM (RFNA) NAIL CONSTRUCT AND A VARIABLE ANGLE (VA) CONDYLAR PLATE CONSTRUCT WERE REMOVED FROM A FEMUR BECAUSE OF INFECTION. THE DEVICES WERE ORIGINALLY IMPLANTED ON FEBRUARY 16, 2022 AND EXPLANTED ON APRIL 4, 2022. NO ALLEGATIONS WERE MADE ON THE DEVICES FROM THE SURGEON. THE SURGEON REMOVED THE PROXIMAL SCREWS, AND PERFORMED AN AMPUTATION TO REMOVE REMAINING HARDWARE ON ONE PIECE. THE EXACT TOTAL NUMBER OF IMPLANTED SCREWS REMOVED IS UNKNOWN. THE PROCEDURE OUTCOME WAS UNKNOWN. THIS IS REPORT 2 OF 3 FOR (B)(4). THIS REPORT IS FOR A VA CONDYLAR PLATE.

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. EVENT DATE IS UNKNOWN, COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 HISTORY: PART #: 02.124.414S-US, LOT #: L561771, MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: 20 SEP 2017, EXPIRATION DATE: N/A. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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.