BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURVED POSITIONER/IMPACTOR HANDLE

    MDR report key: 1890694 · Received November 1, 2010

    Report

    Report Number
    2249697-2010-01443
    Event Type
    Malfunction
    Date Received
    November 1, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 7, 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
    OH, 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 "THE KNOB THAT TIGHTENS THE ACETABULAR CUP TO THE INSTRUMENT BROKE OFF COMPLETELY FROM THE IMPACTOR HANDLE, AFTER ONLY BEING STRUCK ONCE FOR IMPACTION. USED THE STRAIGHT CUP IMPACTOR FROM THE SET INSTEAD. CUP WASN'T ALL THE WAY DOWN, SO DR PULLED IT ALL THE WAY OUT, PUT IT ON THE STRAIGHT IMPACTOR AND IMPACTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURVED POSITIONER/IMPACTOR HANDLE INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA TACFB00

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention