VA-LCP CONDYLAR PLATE 4.5/5.0 LE 12HO L2

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. H11 ADDITIONAL NARRATIVE: H3, H6: THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. THE J&J MEDTECH ORTHOPAEDICS TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE VA-LCP CONDYLAR PLATE 4.5/5.0 LE 12HO L2 HAS DAMAGE AT THE 12 HOLE. THE THREADS WERE STRIPPED AND PARTIALLY BROKEN; SOME REMNANTS ARE STILL ATTACHED. FRAGMENTS WERE NOT RECEIVED. THE OBSERVED CONDITION OF THE DEVICE CAN BE CONSISTENT WITH A COMPONENT FAILURE THAT WAS CAUSED BY EXPOSURE TO UNINTENDED FORCES. A DIMENSIONAL INSPECTION FOR THE VA-LCP CONDYLAR PLATE 4.5/5.0 LE 12HO L2 WAS NOT PERFORMED DUE TO POST MANUFACTURING DAMAGE. A FUNCTIONAL TEST WAS WAS NOT PERFORMED AS THE MATING SCREW WAS NOT RECEIVED TO ASSESS THE INTERACTION BETWEEN THE DEVICES, HOWEVER DUE TO OBSERVED CONDITION THE INABILITY TO ASSEMBLE AND/OR DISASSEMBLE/RELEASE MATING DEVICES MAY PRESENT DURING THE PROCEDURE. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE VA-LCP CONDYLAR PLATE 4.5/5.0 LE 12HO L2 WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY REVIEW PART NUMBER: 02.124.413S LOT NUMBER: 39714P2 MANUFACTURING SITE: MEZZOVICO RELEASE TO WAREHOUSE DATE: 14 NOV 2024 EXPIRATION DATE: 31 OCT 2034 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE STERILE FINISHED LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 DURING AN ORIF LEFT FEMUR, THE CURVED CONDYLAR PLATING SYSTEM WAS BEING USED. THE PLATE WAS LOADED ON THE AIMING ARM CORRECTLY, UPON INSERTION, THE AIMING ARE CAME OFF OF THE PLATE. THE SURGEON TOOK THE PLATE OUT AND TRIED TO RECONNECT THE AIMING ARM TO THE PLATE AND REALIZED THE HOLE WAS STRIPPED AND WOULD NOT CONNECT CORRECTLY TO USE THE PLATE. ANOTHER PLATE OF SAME SIZE WAS NOT AVAILABLE TO BE USED SO THE SURGEON OPTED TO USE A 10 HOLE (2 HOLE SHORTER) PLATE. THERE WAS A SURGICAL DELAY OF FIFTEEN (15) MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4) THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.