BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE HANDLE/QUICK COUPLING W/ ROTATING CAP

    MDR report key: 21256696 · Received January 28, 2025

    Report

    Report Number
    8030965-2025-00950
    Event Type
    Malfunction
    Date Received
    January 28, 2025
    Date of Event
    January 15, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTD
    UDI-DI
    07611819521407
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. CORRECTED: D9, G1. DEVICE HISTORY REVIEW PART NUMBER: 03.118.111 LOT NUMBER: T176405 MANUFACTURING SITE: TUTTLINGEN RELEASE TO WAREHOUSE DATE: 17-APR-2019. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER AND A NC NR-0121256 WAS IDENTIFIED FOR THIS LOT. THE ISSUE WITHIN THE NR-0121256 IS REGARDING WATER MONITORING SAMPLES AND IS NOT RELATED TO THE ISSUE DESCRIBED WITHIN THIS COMPLAINT. THE NECESSARY ACTIONS TO ENSURE THE FINAL PRODUCT QUALITY HAVE BEEN TAKEN AND DOCUMENTED IN THE APPROPRIATE QUALITY SYSTEM. THE NC HAVE NO IMPACT TO THE COMPLAINT CONDITION. THE FINAL QUALITY RELEASE CRITERIA WERE MET BEFORE THIS BATCH WAS RELEASED FOR DISTRIBUTION. 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 DURING A PROCEDURE ON (B)(6) 2025, THE HANDLE WAS BROKEN. THERE WAS NO IMPACT TO OR DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1548933 SILICONE HANDLE/QUICK COUPLING W/ ROTATING CAP FORCEPS HTD SYNTHES GMBH T176405 07611819521407

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown