BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OFFSET BROACH HANDLE, STD.

    MDR report key: 1962898 · Received December 22, 2010

    Report

    Report Number
    2249697-2010-01846
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 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
    JA
    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, "DURING THE HIP SURGERY, WHEN THE SURGEON WAS USING THE OFFSET BROACH HANDLE, IT WAS BROKEN. AS A RESULT, IT COULD NOT HOLD ANY BROACHS. THEREFORE, HE USED A SPARE HANDLE INSTEAD OF IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OFFSET BROACH HANDLE, STD. INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA H99E102

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention