BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPAIR MAESTRO DRILL

    MDR report key: 1983786 · Received January 11, 2011

    Report

    Report Number
    1811755-2011-00060
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Date of Event
    December 18, 2010
    Report Date
    December 18, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBB
    PMA / PMN Number
    K041754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AND AN INVESTIGATION IS ANTICIPATED. A FOLLOW UP REPORT WILL BE SUBMITTED IF THE INVESTIGATION RESULTS REQUIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE CLEANING PROCESS AT THE USER FACILITY, A HOLE WAS DISCOVERED IN THE HOSE PORTION OF THE PNEUMATIC DRILL. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, SO THERE WAS NO PT 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 REPAIR MAESTRO DRILL MOTOR, DRILL, PNEUMATIC HBB STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK