BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO DRILL

    MDR report key: 2200959 · Received July 1, 2011

    Report

    Report Number
    1811755-2011-02308
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 7, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBB
    PMA / PMN Number
    K041754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND UPON INSPECTION, A HOLE WAS DISCOVERED IN THE PNEUMATIC HOSE ASSEMBLY. IT IS UNKNOWN HOW THE HOSE DAMAGE OCCURRED, BUT MAY BE THE RESULT OF MISHANDLING. THE HOSE ASSEMBLY WAS REPLACED 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, A HOLE WAS DISCOVERED IN TH HOSE PORTION OF THE PNEUMATIC DRILL. NO OIL LEAKAGE FROM THE DEVICE WAS REPORTED. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, SO THERE WAS NO PATIENT 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 HBB STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK