BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO SAGITTAL SAW

    MDR report key: 3872090 · Received June 13, 2014

    Report

    Report Number
    0001811755-2014-02143
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 20, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON VISUAL INSPECTION, THE DEVICE WAS FOUND TO HAVE THIRD PARTY REPAIR TO THE MOTOR. THE DEVICE WILL BE REPAIRED AND RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET UP AT THE USER FACILITY, THE MICRO SAGITTAL SAW WAS OPERATING WITHOUT USER ACTIVATION. IT WAS REPORTED THAT THERE WAS NO ASSOCIATED PROCEDURE. NO PATIENT INVOLVEMENT, 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
    349011 MICRO SAGITTAL SAW DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1