BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO SAGITTAL SAW

    MDR report key: 2972289 · Received February 21, 2013

    Report

    Report Number
    0001811755-2013-00343
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE EVALUATION, THE MOTOR WAS FOUND TO THE CORRODED AND THE PRINTED CIRCUIT BOARD (FLEX ASSEMBLY) WITHIN THE MOTOR WAS FOUND TO BE DAMAGED, WHICH IS A PROBABLE CAUSE OF THE BIAS CURRENT ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER FACILITY, THE SAW CAUSED A BIAS CURRENT WARNING TO BE DISPLAYED ON THE CONSOLE, SIGNALING A CONDITION OCCURRED IN WHICH THE DEVICE HAS THE POTENTIAL TO RUN WITHOUT USER ACTIVATION. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75569 MICRO SAGITTAL SAW DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1