BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM VA PPFX GT RING ATTCHMT PLATE/SMALL/RIGHT/STERILE

    MDR report key: 23426349 · Received October 30, 2025

    Report

    Report Number
    8030965-2025-10880
    Event Type
    Malfunction
    Date Received
    October 30, 2025
    Date of Event
    October 12, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    UDI-DI
    07612334218544
    PMA / PMN Number
    K210207
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    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: D10. CORRECTED: G1. H3, H6: THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE INVESTIGATION PERFORMED FOUND THAT: DUE TO THE SEVERELY WORN CONDITION OF THE THREADS, IT WAS NOT POSSIBLE TO REMEASURE THE THREAD PROFILE OR ANY OTHER THREAD-RELATED CHARACTERISTICS OF THE CONNECTING SCREW, NOR TO PERFORM FUNCTIONAL TESTING. THE CONNECTING SCREW IS FULLY MANUFACTURED BY AN EXTERNAL SUPPLIER, WHO PERFORMS IN-PROCESS INSPECTIONS DURING PRODUCTION. IN ADDITION, THE RARON MANUFACTURING SITE PERFORMS INCOMING INSPECTIONS ON SUPPLIED CONNECTING SCREWS IN ACCORDANCE WITH THE APPLICABLE INSPECTION PLAN (REF. SE_813919 REV. AD IN WHICH THE THREAD FEATURES ¿CTQ1.1 AND CTQ1.2¿ ARE DIMENSIONALLY INSPECTED WITH AN AQL4.0 FREQUENCY AND THE SURFACE OF THE SCREW IS VISUALLY INSPECTED ALSO WITH AN AQL4.0 FREQUENCY): THE REVIEW OF THE INSPECTION RECORDS DIDN¿T REVEAL ANY NON-CONFORMANCES / MANUFACTURING IRREGULARITIES. THE OBSERVED DAMAGE PATTERN IS NOT COMPATIBLE WITH THE MANUFACTURING PROCESSES, HANDLING METHODS, OR ASSEMBLY TOOLS USED EITHER AT THE SUPPLIER¿S PRODUCTION SITE OR DURING INCOMING INSPECTION AT THE RARON SITE. FURTHERMORE, IF SUCH EXTENSIVE THREAD DAMAGE HAD BEEN PRESENT PRIOR TO PRODUCT RELEASE, IT WOULD HAVE BEEN IDENTIFIED DURING SUPPLIER IN-PROCESS INSPECTIONS AND/OR DURING INCOMING INSPECTION AT THE RARON MANUFACTURING SITE. BASED ON THESE FINDINGS, THE DAMAGE IS ASSESSED AS POST-PRODUCTION, AND THE COMPLAINED ISSUE CAN NOT BE CONFIRMED AS MANUFACTURING RELATED. THE OBSERVED CONDITION OF THE DEVICE WAS CONSISTENT WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCES. A DIMENSIONAL INSPECTION WAS UNABLE TO BE PERFORMED DUE TO THE POST-MANUFACTURING DAMAGE. A FUNCTIONAL TEST WAS UNABLE TO BE PERFORMED DUE TO THE POST-MANUFACTURING DAMAGE. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE VA LOCKING PPFX GREATER TROCHANTER RING 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: DHR REVIEW FOR THE FOLLOWING DEVICE CONDUCTED: PRODUCT CODE # 02.221.100S. LOT # 78097P2. MANUFACTURING DATE: 09/05/2025. EXPIRY DATE: 09/01/2035. NO NON-CONFORMANCE / MANUFACTURING IRREGULARITIES WERE IDENTIFIED. PART NUMBER: 02.221.180, LOT NUMBER: 59431P4, MANUFACTURING SITE: RARON, A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE COMPONENT IS PURCHASED DIRECTLY FROM THE SUPPLIER, THE ITEMS ARE CHECKED, AND NO NON-CONFORMITY HAS BEEN FOUND. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    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: D9. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 · 0

    IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2025, THE TWO (2) GT RING PLATES DID NOT CONNECT WITH EITHER OF THE PROXIMAL FEMUR PLATES. THE SURGEON ATTEMPTED MULTIPLE TIMES WITH THE SCREWDRIVER AND BY HAND BUT ALL EFFORTS FAILED. EVENTUALLY, THEY OPENED A HOOK PLATE TO CONTINUE WITH THE FIXATION. THIS WAS THE FIRST TIME THE SURGEON WAS USING THE GT RING PLATE IN COMBINATION WITH THE PROXIMAL FEMUR PLATE. THERE WAS NO PATIENT HARM AND NO ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15116 3.5MM VA PPFX GT RING ATTCHMT PLATE/SMALL/RIGHT/STERILE PLATE, FIXATION, BONE HRS SYNTHES GMBH 78097P2 07612334218544

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CONNECSCR F/VA LOCKING PPFX GREATER TROC| VA LOCKING PPFX GREATER TROCHANTER RING| VA-LCP PPFX PROXIMAL FEMUR HOOK PLATE 3.| VA-LCP PPFX PROXIMAL FEMUR PLATE 3.5/4.5| VA-LCP PPFX PROXIMAL FEMUR PLATE 3.5/4.5