LCP METAPHYSPL 3.5 6HO L86 TI

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: ADDED: D4 EXPIRATION DATE, H4. CORRECTED: D4 PRIMARY UDI NUMBER, G1. H3, H6: PHOTO INVESTIGATION. THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES; HOWEVER, X-RAY WERE PROVIDED FOR REVIEW. THE X-RAY INVESTIGATION REVEALED THE PLATE WAS OBSERVED AND DEFORMATION WAS IDENTIFIED AS WELL AS A CRACK NEAR THE SECOND SCREW HOLE. THE REPORTED EVENT CAN BE CONFIRMED. WITH THE INFORMATION PROVIDED IS NOT POSSIBLE TO DETERMINE A POTENTIAL CAUSE AT THIS MOMENT. THE MODE OF FAILURE OF THE DEVICE IS MULTI-FACTORIAL AND CONSIDERATION MUST BE GIVEN TO ALL OTHER POTENTIAL INFLUENCES SUCH AS SURGICAL PROCESS, PATIENT VARIABLES (E.G. ACTIVITY LEVEL AND USE), ANATOMICAL CONSIDERATIONS AND PATIENT CHANGES OVER TIME. ANY CONCLUSIONS FROM THE INVESTIGATIONAL INPUT PROVIDED HAVE TO BE PLACED INTO CONTEXT WITH ALL OTHER RELEVANT FACTORS. AS THE DEVICE WAS NOT RETURNED, AND AS-RECEIVED CONDITION COULD NOT BE ASSESSED, A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE LCP METAPHYSPL 3.5 6HO L86 TI WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE. PRODUCT CODE: 423.406S-15. LOT NUMBER: 10687P5. IT WAS ELECTRONICALLY REVIEWED AND NO NONCONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON: 12 APR 2024. MANUFACTURING SITE: JABIL GRENCHEN. EXPIRY DATE: 01 APR 2034. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H11: ADDITIONAL NARRATIVE: D2: COMPLETE COMMON NAME: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT PROVIDED 10687P5 WAS NOT ABLE TO BE VALIDATED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO DEVICE MARKETED IN THE USA.

Description of Event or Problem

IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT ORIF SURGERY WITH METAPHYSEAL PLATE FOR RADIAL SHAFT FRACTURES. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY THE PATIENT DEVELOPED NON-UNION, AND THE PLATE BROKE AT THE DISTAL PART. THE REVISION SURGERY IS SCHEDULED FOR (B)(6) 2026 WHERE THE PLATE WILL BE REMOVED, THE NON-UNION SITE WILL BE FRESHENED, BONE GRAFTING WILL BE PERFORMED AND TCP EXTRA-LONG WILL BE USED FOR FIXATION.