BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AO LARGE REAMER ATTACHMENT

    MDR report key: 2201024 · Received July 1, 2011

    Report

    Report Number
    1811755-2011-02394
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE CONTINUED TO SPIN WHEN THE TRIGGER WAS RELEASED. A BACK UP DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ALLEGATION OF ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AO LARGE REAMER ATTACHMENT KIJ STRYKER INSTRUMENTS KALAMAZOO 10253

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK