BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIXED DURAGUARD, 16MM

    MDR report key: 2201017 · Received July 1, 2011

    Report

    Report Number
    1811755-2011-02363
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 23, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER, THE DRILL ATTACHMENT HEATED UP. THIS EVENT DID NOT OCCUR IN A SURGICAL ENVIRONMENT, SO THERE WAS NO PATIENT INVOLVEMENT. NO USER INJURY WAS REPORTED, AND NO OTHER ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXED DURAGUARD, 16MM HBE STRYKER INSTRUMENTS KALAMAZOO 10162

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK