BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBULINK SYNDESMOSIS REPAIR KIT TI

    MDR report key: 20226809 · Received September 16, 2024

    Report

    Report Number
    8030965-2024-11546
    Event Type
    Malfunction
    Date Received
    September 16, 2024
    Date of Event
    September 3, 2024
    Report Date
    September 16, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTN
    UDI-DI
    07612334226365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. 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 (DHR): PART # FGS-1100 SYNTHES LOT # 22E013 SUPPLIER LOT # 22E013 RELEASE TO WAREHOUSE DATE: 27 JUN 2022 SUPPLIER: ROBLING MEDICAL, INC NO NCR'S 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. 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 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

    ADDITIONAL INFORMATION RECEIVED STATES THAT THE PATIENT WAS STABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN ORIF WITH THE FIBULINK FOR ANKLE FRACTURE. THE SILVER GUIDE TUBE WAS GRIPPED WITH A KOCHER FORCEPS. THE FIBULINK WAS PULLED, AND THE TENSIONING CAP WAS TURNED; HOWEVER, NO TENSION WAS APPLIED. WHEN THE TENSIONING CAP WAS PULLED A LITTLE HARDER, THE SILVER GUIDE TUBE AND THE GOLD TUBE CAME OFF TOGETHER. THE SURGEON ATTEMPTED TO PUT THE SILVER TUBE BACK IN AGAIN, FOLLOWED BY THE GOLD TUBE; HOWEVER, THE PARTS COULD NOT BE CONNECTED PROPERLY. THEREFORE, ALL THE FIBULINK WAS REMOVED. A SPARE SET WAS USED FOR SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1496698 FIBULINK SYNDESMOSIS REPAIR KIT TI WASHER, BOLT NUT HTN SYNTHES GMBH 22E013 07612334226365

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown FIBULINK SYNDESMOSIS REPAIR KIT TI.