BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO DRILL WITH HANDSWITCH

    MDR report key: 2891101 · Received November 14, 2012

    Report

    Report Number
    1811755-2012-04023
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 10, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBB
    PMA / PMN Number
    K041754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE DEVICE WOULD CONTINUE TO OPERATE IN RUN MODE WITHOUT ANY USER ACTIVATION. A BACKUP DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES AND NO ALLEGED DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAESTRO DRILL WITH HANDSWITCH HBB STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK