BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO HANDSWITCH DRILL

    MDR report key: 2233123 · Received July 22, 2011

    Report

    Report Number
    1811755-2011-02621
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBB
    PMA / PMN Number
    K041754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY THE MANUFACTURER AND EVENT AS REPORTED WAS CONFIRMED. THE NEEDLE VALVE WAS DAMAGED AND THE VALVE WAS STUCK IN OPEN (RUN) POSITION. THE NEEDLE VALVE WHICH REGULATES THE INLET GAS THAT ACTUATES THE MOTOR WAS FOUND TO HAVE MALFUNCTIONED PREVENTING THE O-RING ON THE NEEDLE VALVE FROM COMPRESSING INTO THE VALVE BORE. THIS FAILURE CAN RESULT IN CONTINUOUS GAS FLOW ENTERING AND ACTUATING THE MOTOR CAUSING RUN ON. THE DRILL WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRILL WOULD RUN IN SAFE MODE. THIS WAS NOTICED WHEN THE DEVICE WAS BEING SERVICED BY THE MANUFACTURER. THERE WAS NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK