4.5 VA-LCP CURVED COND PL/6 HOLE/159/LFT

Description of Event or Problem

IT WAS REPORTED THAT ON (B)(6) 2023 DURING A PROCEDURE THERE WAS A INTER-PROSTHETIC FRACTURE WITH A DISTAL FEMUR FRACTURE. A FRN WAS INSERTED AND THEN TWO PLATES WERE INSERTED DISTALLY. A LATERAL PLATE WAS INSERTED AND THE SAME PLATE, BUT CONTRALATERAL SIDE WAS PUT ON THE MEDIAL SIDE. DURING THE FRN, THE PROXIMAL PORTION BECAME SNAGGED UP. THE DRIVE CAP BROKE DURING MALLEATING. WHILE INSERTING BOTH PLATES DISTALLY, THE CENTER HOLE DID NOT LOCK INTO THE PLATE. UNSURE IF IT WAS DUE TO THE TRAFFIC OF THE SCREWS, AND MAKING THE SCREWS SKIVE OFF AXIS. DEPTH GAUGE WAS ALSO BENT IN THE PROCESS OF MEASURING FOR SCREWS. THERE WERE FOUR (4) MINUTES OF SURGICAL DELAY. THIS COMPLAINT INVOLVES FIVE (5) DEVICE. THIS REPORT IS FOR ONE (1) 4.5 VA-LCP CURVED COND PL/6 HOLE/159/LFT THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

Additional Manufacturer Narrative

PRODUCT COMPLAINT (B)(4). 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: ADDITIONAL PRO-CODES: HRS, HWC COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A J&J SALES REPRESENTATIVE. 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.