BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DHS/DCS COUPLING SCREW

    MDR report key: 1190703 · Received October 6, 2008

    Report

    Report Number
    2530088-2008-00047
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 11, 2008
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HWC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. SUBJECT DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED. NO INVESTIGATION COULD BE PERFORMED; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER AVAILABLE. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING DATE WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    DURING AN ORIF FOR A FRACTURED RIGHT HIP, THE TIP OF THE DHS/DCS COUPLING SCREW BROKE OFF INSIDE THE HEAD OF A DHS/DCS LAG SCREW. SURGEON DECIDED NOT TO ATTEMPT REMOVAL OF BROKEN TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DHS/DCS COUPLING SCREW DHS/DCS/DHHS COUPLING SCREWS HWC SYNTHES BRANDYWINE NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR