BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBULINK® SYNDESMOSIS REPAIR KIT/SS

    MDR report key: 13180232 · Received January 6, 2022

    Report

    Report Number
    1719045-2022-00001
    Event Type
    Malfunction
    Date Received
    January 6, 2022
    Date of Event
    December 9, 2021
    Manufacturer
    MONUMENT DEPUY SYNTHES PRODUCTS INC
    Product Code
    HTN
    UDI-DI
    00863176000300
    PMA / PMN Number
    K173550
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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. H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART #: FGS-1000; SYNTHES LOT #: 21E014; SUPPLIER LOT #: 21E014; RELEASE TO WAREHOUSE DATE: 01 JUL 2021; SUPPLIER: ROBLING MEDICAL INC. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. H6: THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. G1.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2021, THE SURGEON HAD AN ISSUE REGARDING AN ADVERSE EVENT OF REPAIR PTS SYDESMOTIC RUPTURE USING DEPUY SYNTHES TRAUMA PRODUCTS, FIBULINK, FGS-1000. IT WAS UNKNOWN HOW IT WAS DISCOVERED. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE(1) DEVICE. THIS REPORT IS FOR (1) FIBULINK® SYNDESMOSIS REPAIR KIT/SS. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 FIBULINK DEVICES FAIL INTRAOPERATIVELY. AND SURGEON HAD TO OPEN A FIBULINK REMOVAL KIT AS A RESULT. SURGEON RETRIEVED BOTH DAMAGED IMPLANTS AND THERE WAS INCREASED OPERATIVE TIME OF ROUGHLY THIRTY (30) MINUTES. THE ONLY IMPACT ON THE PATIENT WAS THAT THE SURGEON NEEDED TO USE A SCREW INSTEAD OF HIS INTENDED PLAN OF USING A FIBULINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1348093 FIBULINK® SYNDESMOSIS REPAIR KIT/SS WASHER, BOLT NUT HTN MONUMENT DEPUY SYNTHES PRODUCTS INC FGS-1000 21E014 00863176000300

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Unknown