BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTION HANDLE

    MDR report key: 2070947 · Received April 19, 2011

    Report

    Report Number
    2249697-2011-00511
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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. IF DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "HANDLE NO LONGER LOCKS INTO THE IMPACTORS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPACTION HANDLE INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA N3V24

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other