BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAL HEAD HANDLE

    MDR report key: 1903600 · Received November 16, 2010

    Report

    Report Number
    2249697-2010-01549
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 22, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "WHILE ATTEMPTING TO REMOVE THE BIPOLAR TRIAL HEAD THREADED END OF HANDLE DISLODGES AND STAYS IN UHT BIPOLAR TRIAL HEADS, ONCE THIS HAPPENS TRIAL HANDLE IS RENDERED USELESS AS THREADED TIP NO LONGER STAYS IN THE HANDLE. NO PT CONSEQUENCES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAL HEAD HANDLE INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA F4H7565

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention