4.5MM VA-LCP CURVED CONDYLAR PLATE/14HOLE/301MM/LT-STER

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. H3, H6: THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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.

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. H10 ADDITIONAL NARRATIVE: H3, H4, H6: THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THERE WAS NO DEFECTS WITH THE VA-LCP CONDYLAR PLATE 4.5/5.0 LE 14HO L3. THE DEVICE DOES NOT PRESENT ANY VISIBLE DAMAGE AROUND THE MATING HOLE OF THE INSERTION HANDLE WHICH COULD HAVE CONTRIBUTED TO THE MATING ISSUES REPORTED. THE VA-LCP CONDYLAR PLATE 4.5/5.0 SURGICAL TECHNIQUE GUIDE WAS REVIEWED. THE FOLLOWING RELEVANT STATEMENTS WERE FOUND. INDICATIONS: POSITION THE INSERTION HANDLE SO THAT THE SPHERICAL PINS ON THE UNDERSIDE ALIGN WITH THE DIMPLES AROUND THE FIRST COMBI-HOLE OF THE APPROPRIATE VA-LCP CONDYLAR PLATE 4.5/5.0. INSERT THE LOCKING BOLT WITH NUT INTO THE THROUGH HOLE OF THE INSERTION HANDLE. THREAD THE TIP INTO THE THREADED PORTION OF THE COMBI-HOLE UNTIL IT IS FIRMLY FINGER TIGHT. TIGHTEN THE LOCKING NUT. PRECAUTIONS: - IT IS IMPORTANT TO PLACE THE PLATE ON A FLAT SURFACE WHEN POSITIONING THE INSERTION HANDLE AND LOCKING BOLT TO ENSURE THE LOCKING BOLT IS PERPENDICULAR TO THE PLATE AND NOT CROSS-THREADED INTO THE COMBI-HOLE. PER THE EVENT DESCRIPTION, IT IS STATED THAT AN "ANCILLARY LOCKING SLEEVE" DID NOT LOCK INTO THE PLATE, SUPPOSING THAT IS REFERRING TO THE INSERTION HANDLE (03.231.020 INSERTION HANDLE FOR UNIVERSAL AIMING ARM FOR VA-LCP CONDYLAR PLATE 4.5/5.0). IT IS RECOMMENDED TO POSITION THE PLATE ACCORDING TO THE INSTRUCTIONS FOR USE IN ORDER TO SECURE THE ALIGNMENT OF THE SYSTEM AND PROPER FUNCTIONALITY. A DIMENSIONAL INSPECTION WAS PERFORMED FOR THE VA-LCP CONDYLAR PLATE 4.5/5.0 LE 14HO L3 AND MET SPECIFICATIONS. A FUNCTIONAL TEST WAS UNABLE TO BE PERFORMED AS THE INSERTION HANDLE WAS NOT RETURNED. THE COMPLAINT CONDITION WAS NOT REPLICATED. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE VA-LCP CONDYLAR PLATE 4.5/5.0 LE 14HO L3 WAS FOUND TO HAVE NO DAMAGE OR DEFECTS. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED. 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. DEVICE HISTORY REVIEW (DHR): PART NUMBER: 02.124.415S. LOT NUMBER: 4651P84. MANUFACTURING SITE: MEZZOVICO. RELEASE TO WAREHOUSE DATE: 23 MAR 2023. EXPIRATION DATE: 1 MAR 2033. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE STERILE FINISHED 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.

Description of Event or Problem

DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN FRANCE AS FOLLOWS: IT WAS REPORTED DURING OSTEOSYNTHESIS OF THE FEMUR, ON (B)(6) 2023, IT WAS FOUND THAT THE ANCILLARY LOCKING SLEEVE DID NOT LOCK INTO THE PLATE. ANOTHER PLATE WAS USED TO PERFORM THE INTERVENTION. NO CLINICAL CONSEQUENCES WERE OBSERVED IN THE PATIENT. THIS REPORT IS FOR ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/LEFT. THIS IS REPORT 1 OF 2 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: D9: COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. H3, H6: 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 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 FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FIFTEEN TO TWENTY MINUTE DELAY. THE SURGEON HAD TO PLACE A SHORTER PLATE BECAUSE A SECOND IDENTICAL (LENGTH) PLATE TO THE FAILED ONE WAS NOT AVAILABLE.

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. D2: ADDITIONAL PROCODES: HRW, HWC; D10: DATE OF CONCOMITANT THERAPY IS (B)(6) 2023. 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.