BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 20MM

    MDR report key: 22385431 · Received July 2, 2025

    Report

    Report Number
    8030965-2025-06742
    Event Type
    Malfunction
    Date Received
    July 2, 2025
    Date of Event
    June 11, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    UDI-DI
    07611819425262
    PMA / PMN Number
    K103243
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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: H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. H3, H6: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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 HISTORY REVIEW ==> STERILE PART # 04.211.020TS STERILE LOT # 382L658 RELEASE TO WAREHOUSE DATE: 26.MAR.2025. EXPIRATION DATE: 01.MAR.2030. SUPPLIER: FRÜH VERPACKUNGSTECHNIK AG. MANUFACTURING SITE: WERK SELZACH. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. ----------------------------------------------------------- NON-STERILE PART # 04.211.020 NON-STERILE LOT # 54853P6 MANUFACTURING SITE: WERK SELZACH RELEASE TO WAREHOUSE DATE: 27.FEB.2025. SUPPLIER: SYNTHES USA HQ, INC. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT 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.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY FOR DISTAL HUMERUS CONDYLE FRACTURE. THE SURGEON INSERTED AND TEMPORARILY TIGHTENED THE LOCKING SCREW, AND OTHER SCREWS WERE ALSO INSERTED. WHEN THE SURGEON TRIED TO FULLY TIGHTEN THE LOCKING SCREW, THERE WAS NO RESISTANCE, AND WHEN THE SURGEON REMOVED THE SCREW TO CHECK, IT WAS FOUND TO HAVE BROKEN JUST BELOW THE SCREW HEAD. THE SURGEON COMMENTED THAT PERHAPS THE LOCKING SCREW WAS TEMPORARILY TIGHTENED AND THEN BITTEN AGAIN STRONGLY WITH FORCEPS, WHICH PUT STRESS ON THE LOCKING SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177615 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 20MM SCREW, FIXATION, BONE HWC SYNTHES GMBH 382L658 07611819425262

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown