BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO DRILL

    MDR report key: 2233195 · Received July 22, 2011

    Report

    Report Number
    1811755-2011-02653
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBB
    PMA / PMN Number
    K041754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY THE MFR AND THE REPORTED FAILURE BY THE CUSTOMER WAS DUPLICATED. UPON VISUAL EXAMINATION, IT WAS FOUND THAT THE MOTOR INLET HOSE WAS RIPPED APART FROM THE SWIVEL ASSEMBLY. THE MOTOR INLET HOSE CONNECTS TO THE SWIVEL ASSEMBLY; HIGH PRESSURE GAS RUNS THROUGH THE INLET HOSE AND IF NOT FITTED CORRECTLY CAN CAUSE THE MOTOR HOSE ASSEMBLY TO DISASSEMBLE OR BLOW APART FROM THE SWIVEL ASSEMBLY. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEAD OF THE DRILL CASING CAME OFF DURING A CASE. A BACKUP WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO MEDICAL INTERVENTION REQUIRED AND NO DELAY IN THE PROCEDURE.

    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