BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO DRILL

    MDR report key: 1923966 · Received December 9, 2010

    Report

    Report Number
    1811755-2010-01949
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBB
    PMA / PMN Number
    K041754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR AND AN INVESTIGATION IS ANTICIPATED. A F/U REPORT WILL BE SUBMITTED IF THE INVESTIGATION RESULTS REQUIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE DRILL HEATED UP AND A HOLE WAS DISCOVERED IN THE HOSE PORTION OF THE PNEUMATIC DRILL. BACKUP EQUIPMENT WAS USED TO COMPLETE THE PROCEDURE, WITH NO REPORT OF A DELAY. THERE WERE NO REPORTS OF ANY OIL LEAKAGE FROM THE DEVICE. NO PT OR 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 MOTOR, DRILL, PNEUMATIC HBB STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK