BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBULINK® SYNDESMOSIS REPAIR KIT/SS

    MDR report key: 16808630 · Received April 25, 2023

    Report

    Report Number
    8030965-2023-05244
    Event Type
    Malfunction
    Date Received
    April 25, 2023
    Date of Event
    April 7, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTN
    UDI-DI
    00863176000300
    PMA / PMN Number
    K162805
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    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. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: PART# FGS-1000. SYNTHES LOT # 22E020. SUPPLIER LOT # 22E020. RELEASE TO WAREHOUSE DATE: 01 NOV 2022. 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. 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 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(4) 2023 A FIBULINK DEVICE WAS BROKEN. THERE WAS A SURGICAL DELAY OF SURGERY OF 15 MINUTES, ADDITIONAL RADIATION EXPOSURE IS LESS THAN 2 MINS. THE DEVICE WAS IMPLANTED AND IT BROKE. PART OF THE IMPLANT WAS REMOVED IMMEDIATELY WHICH LEFT A TIBIAL SCREW STUCK IN THE PATIENT. THEY USED THE SYNTHES SCREW REMOVAL DEVICE TO REMOVE THE TIBIAL IMPLANT. IT WAS REMOVED SUCCESSFULLY NO FRAGMENT WAS LEFT IN THE PATIENT. PATIENT OUTCOME WAS SATISFACTORY. THIS REPORT INVOLVES ONE (1) FIBULINK(R) SYNDESMOSIS REPAIR KIT/SS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624767 FIBULINK® SYNDESMOSIS REPAIR KIT/SS WASHER, BOLT NUT HTN SYNTHES GMBH FGS-1000 22E020 00863176000300

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Unknown