BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO DRILL

    MDR report key: 2082068 · Received April 26, 2011

    Report

    Report Number
    1811755-2011-01335
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    March 28, 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
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL WAS RECEIVED BY THE MANUFACTURER, HOWEVER THE COMPLAINT COULD NOT BE REPLICATED. BASED ON THE RESULTS OF THE DEVICE EVALUATION, THE DRILL OPERATED WITHIN TEMPERATURE SPECIFICATIONS. PREVENTATIVE MAINTENANCE WAS PERFORMED AND THE DEVICE WAS RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LUMBAR LAMINECTOMY, THE DRILL HEATED UP. BACKUP EQUIPMENT WAS USED TO COMPLETE THE PROCEDURE, WITH NO REPORT OF A DELAY. NO PATIENT OR 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