BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO DRILL

    MDR report key: 2243677 · Received July 28, 2011

    Report

    Report Number
    1811755-2011-02699
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 6, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBB
    PMA / PMN Number
    K041754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL WAS RECEIVED BY THE MFR AND THE COMPLAINT WAS CONFIRMED. THE PNEUMATIC HOSE ASSEMBLY WAS FOUND TO BE DAMAGED, SO THE ASSEMBLY WAS REPLACED. ADD'L PREVENTATIVE MAINTENANCE WAS ALSO PERFORMED. THE DRILL WILL BE RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PNEUMATIC DRILL LEAKED AN UNREPORTED SUBSTANCE. THERE WAS NO PT INVOLVEMENT, AND NO USER INJURIES REPORTED WITH THIS EVENT. ATTEMPTS TO OBTAIN ADD'L INFO WERE UNSUCCESSFUL.

    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