BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO DRILL WITH HANDSWITCH

    MDR report key: 3101499 · Received May 9, 2013

    Report

    Report Number
    0001811755-2013-01065
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HBB
    PMA / PMN Number
    K041754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE DEVICE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS CONFIRMED FOR RUN ON BY THE REPAIR TECHNICIAN THROUGH FUNCTIONAL TESTING, DISASSEMBLY AND VISUAL INSPECTION. THE NEEDLE VALVE WAS UNPRESSING FROM THE HOUSING. THE VALVE LIKELY BECAME DISLODGED DUE TO WEAR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MAESTRO DRILL WITH HANDSWITCH WAS RUNNING WITHOUT USER ACTIVATION DURING PERFORMANCE TESTING. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MAESTRO DRILL WITH HANDSWITCH WAS RUNNING WITHOUT USER ACTIVATION DURING PERFORMANCE TESTING. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204144 MAESTRO DRILL WITH HANDSWITCH PNEUMATIC CRANIAL DRILL MOTOR HBB STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1