BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO DRILL

    MDR report key: 2082086 · Received April 26, 2011

    Report

    Report Number
    1811755-2011-01337
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 28, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBB
    PMA / PMN Number
    K041754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL WAS RETURNED TO THE MANUFACTURER FOR AN UNRELATED ISSUE AND UPON EVALUATION, IT WAS DISCOVERED THAT THE DEVICE LEAKED OIL. TO FULLY REPAIR THE DRILL, NUMEROUS WORN COMPONENTS WERE REPLACED. THE DRILL WAS REPAIRED AND RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER, THE PNEUMATIC DRILL LEAKED OIL. THIS EVENT DID NOT OCCUR IN A SURGICAL ENVIRONMENT, SO THERE WAS NO PATIENT 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 MAESTRO DRILL HBB STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK