BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO DRILL WITH HANDSWITCH

    MDR report key: 2130044 · Received May 5, 2011

    Report

    Report Number
    1811755-2011-01531
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 7, 2011
    Manufacturer
    STRYKER INSTRUMENT KALAMAZOO
    Product Code
    HBB
    PMA / PMN Number
    K041754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED BY THE MANUFACTURER, AND THE COMPLAINT WAS CONFIRMED. BASED ON THE QUALITY INVESTIGATION, THE DRILL'S HANDSWITCH ASSEMBLY BECAME DISPLACED, WHICH DISABLED THE SAFETY MODE AND ALLOWED THE DRILL TO OPERATE WHEN NOT INTENDED. IT IS UNK HOW THE HANDSWITCH ASSEMBLY BECAME DISPLACED. THE HANDSWITCH WAS REPAIRED AND ADDITIONAL PREVENTATIVE MAINTENANCE WAS ALSO PERFORMED. THE DRILL WAS RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER, THE DRILL ACTIVATED WHILE IN SAFE MODE. 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 INSTRUMENT KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK