BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO DRILL

    MDR report key: 1912280 · Received November 23, 2010

    Report

    Report Number
    1811755-2010-01791
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    November 2, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBB
    PMA / PMN Number
    K041754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED IF THE PRODUCT IS RETURNED, AND IF THE INVESTIGATION RESULTS REQUIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE CLEANING PROCESS, THE PNEUMATIC DRILL LEAKED OIL. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, SO THERE WAS NO PT INVOLVEMENT. NO USER INJURY WAS REPORTED, AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAESTRO DRILL MOTOR, DRILL, PNEUMATIC HBB STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK