BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO DRILL

    MDR report key: 2223211 · Received August 16, 2011

    Report

    Report Number
    1811755-2011-03005
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 29, 2011
    Report Date
    July 29, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBB
    PMA / PMN Number
    K041754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY THE MANUFACTURER AND THE COMPLAINT WAS CONFIRMED. A VISUAL EXAMINATION OF THE DRILL CONFIRMED THAT THE PNEUMATIC HOSE WAS TORN OR PUNCTURED. THE HOSE ASSEMBLY WAS REPLACED, AND ADDITIONAL 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 HOSE. NO DELAY OR MEDICAL INTERVENTION WAS REQUIRED. THERE WERE NO ALLEGATIONS OF ADVERSE CONSEQUENCES ASSOCIATED 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