BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO DRILL

    MDR report key: 2233155 · Received July 22, 2011

    Report

    Report Number
    1811755-2011-02622
    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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER ON THE DEVICE WAS NOT READABLE SO THE MANUFACTURER DATE CANNOT BE DETERMINED. THE DEVICE WAS RECEIVED BY THE MANUFACTURER AND THE COMPLAINT WAS CONFIRMED. A VISUAL EXAMINATION OF THE DRILL CONFIRMED THAT THE PNEUMATIC HOSE HAD A HOLE IN IT. THE HOSE ASSEMBLY WAS REPLACED, AND ADD'L PREVENTATIVE MAINTENANCE WAS ALSO PERFORMED. THE DEVICE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A HOLE IN THE DRILL'S HOSE BY THE CONNECTOR. 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 DRILL HBB STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK