4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/LEFT

Additional Manufacturer Narrative

ADDITIONAL NARRATIVE: COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. 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. 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 AN UNKNOWN DATE, THE THREADS DID NOT PROPERLY SEAT WITH THE AIMING ARM JIG CAUSING IT TO NOT PROPERLY WORK WITH THE JIG. THE PLATE DID NOT CONNECT TO THE AIMING ARM DESIGNED FOR USE WITH THE PLATE. A NEW PLATE WAS OPENED AND USED FOR IMPLANTATION. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/LEFT THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

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. H10 ADDITIONAL NARRATIVE: H3, H6: PART: 02.124.417, LOT: 93P8785, MANUFACTURING SITE: MEZZOVICO, RELEASE TO WAREHOUSE DATE: MARCH 04, 2021. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE NOT STERILE DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES CUSTOMER QUALITY (CQ) FOR EVALUATION. THE DEPUY SYNTHES CQ TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE 4.5 VA-LCP CRVD COND PL/16 HOLE/336/LFT REVEALED THAT ONE OF THE LOCKING SCREW HOLES WAS DAMAGED. NO OTHER ISSUES WERE IDENTIFIED. A FUNCTIONAL TEST COULD NOT BE PERFORMED AS THE MATING DEVICE WAS NOT RETURNED. THEREFORE, THE COMPLAINT CONDITION OF UNABLE TO ASSEMBLE CANNOT BE CONFIRMED. THE DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO THE GEOMETRY OF THE DEVICE. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE OVERALL COMPLAINT WAS NOT CONFIRMED FOR THE 4.5 VA-LCP CRVD COND PL/16 HOLE/336/LFT. DAMAGE WAS NOTED ON ONE OF THE LOCKING SCREW HOLES, BUT NO MATING DEVICES WERE RETURNED AND THEREFORE THE FUNCTION OF THE DEVICE CANNOT BE TESTED. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DRAWING/SPECIFICATIONS REVIEWED THE DRAWING REFLECTING THE CURRENT AND MANUFACTURE REVISION WAS REVIEWED. 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.