BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCOLADE OFFSET RASP HANDLE

    MDR report key: 2220600 · Received July 15, 2011

    Report

    Report Number
    2249697-2011-01067
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 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
    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 PHYSICIAN WAS TRYING TO EXTRACT THE BROACH TRAILS AND THE SPRINGS ON THE HANDLES WERE LOOSE CAUSING THE HANDLES TO DISASSEMBLE FROM THE BROACHES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCOLADE OFFSET RASP HANDLE INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other