BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO SAGITTAL SAW

    MDR report key: 3943461 · Received July 18, 2014

    Report

    Report Number
    0001811755-2014-02571
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON VISUAL INSPECTION, THE DIAGNOSTIC ENGINEER FOUND THE ELECTRICAL SOCKETS IN THE MOTOR ASSEMBLY WERE CORRODED. THE DEVICE WAS REPAIRED AND RETURNED TO THE USER FACILITY.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED AFTER THE QUALITY INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE MICRO SAGITTAL SAW WAS RUNNING WITHOUT USER ACTIVATION WHILE IT WAS IN SAFE MODE AND WAS RUNNING WITHOUT USER ACTIVATION AFTER THE TRIGGER WAS RELEASED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY UTILIZING THE SAME DEVICE. NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE MICRO SAGITTAL SAW WAS RUNNING WITHOUT USER ACTIVATION WHILE IT WAS IN SAFE MODE AND WAS RUNNING WITHOUT USER ACTIVATION AFTER THE TRIGGER WAS RELEASED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY UTILIZING THE SAME DEVICE. NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422212 MICRO SAGITTAL SAW DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1