BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO DRILL WITH HANDSWITCH

    MDR report key: 2130041 · Received May 5, 2011

    Report

    Report Number
    1811755-2011-01538
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    March 25, 2011
    Report Date
    April 11, 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 DRILL WAS RECEIVED BY THE MANUFACTURER, AND THE COMPLAINT WAS CONFIRMED. INTERNAL COMPONENTS WERE EVALUATED AND AN O-RING WAS FOUND TO BE DISPLACED. PREVENTING A VALVE FROM SEATING PROPERLY AND STOPPING THE PNEUMATIC AIR FLOW TO THE DRILL. THIS ISSUE WILL RESULT IN THE DRILL CONTINUING TO OPERATE, EVEN WHEN THE TRIGGER IS NOT ACTIVATED. THE DRILL WAS REPAIRED AND ADDITIONAL PREVENTATIVE MAINTENANCE WAS ALSO PERFORMED. THE DEVICE WAS RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER, THE DRILL OPERATED WHEN THE TRIGGER WAS NOT ACTIVATED. THIS EVENT DID NOT OCCUR IN A SURGICAL ENVIRONMENT, SO THERE WAS NO PT 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 MAESTRO DRILL WITH HANDSWITCH HBB STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK