BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE COUPLING SCREW

    MDR report key: 1013290 · Received March 14, 2008

    Report

    Report Number
    2530088-2008-00007
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Date of Event
    February 18, 2008
    Report Date
    February 20, 2008
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HWC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED. NO INVESTIGATION COULD BE MADE, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. SYNTHES IS UNABLE TO DETERMINE THE MANUFACTURE DATE WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    DURING A TFN PROCEDURE, UPON INSERTION OF THE HELICAL BLADE, THE CONNECTING SCREW BROKE AND LODGED IN THE INSERTER. IT TOOK THE SURGEON AN HOUR TO REMOVE THE CONSTRUCT FROM THE PATIENT. ONCE THE CONSTRUCT WAS REMOVED, THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HELICAL BLADE COUPLING SCREW HELICAL BLADE COUPLING SCREW HWC SYNTHES BRANDYWINE NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI HELICAL BLADE| INSERTER