BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PRODUCT 20MM SCREW

    MDR report key: 2945965 · Received January 7, 2013

    Report

    Report Number
    9616680-2013-90047
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    HWC
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE SURGEON WAS USING THE TORQUE WRENCH ON THE SCREW ATTACHING THE CONE CONICAL DURING A REVISION OF PT'S LEFT HIP, AT 140-150 TORQUE, THE SCREW ON THE CONE CONICAL SNAPPED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7714 UNKNOWN PRODUCT 20MM SCREW IMPLANT HWC STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other