BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGHT-NAV COMPATIBLE DUAL-OFFSET ACCOLADE RASP H

    MDR report key: 1082458 · Received July 22, 2008

    Report

    Report Number
    2249697-2008-00213
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 26, 2008
    Report Date
    June 26, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HTR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR EVAL. NO EVAL WILL BE PERFORMED. ADD'L INFO HAS BEEN REQUESTED AND IF REC'D WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "A NEW DOUBLE OFFSET BROACH HANDLE WAS SENT TO OUR HOSPITAL, IT WAS WASHED AND STERILIZED IN THE NORMAL FASHION. UPON INITIAL USE THE BROACH HANDLE BROKE AND WAS UNUSABLE. AS A RESULT OF THE HANDLE BREAKING, THE PT UNDERWENT AN ADD'L 45 MIN OF SURGERY TO RETRIEVE PIECES OF THE HANDLE AND COMPLETE THE SURGERY WITHOUT A RIGHT DOUBLE OFFSET BROACH HANDLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIGHT-NAV COMPATIBLE DUAL-OFFSET ACCOLADE RASP H INSTRUMENT HTR STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other