BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO OSCILLATING SAW

    MDR report key: 2851378 · Received October 29, 2012

    Report

    Report Number
    1811755-2012-03928
    Event Type
    Malfunction
    Date Received
    October 29, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 8, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE EVALUATION, DAMAGED CONTACT PINS WERE FOUND IN THE MOTOR ASSEMBLY, WHICH CAN CONTRIBUTE TO DEVICES OPERATING WITHOUT USER ACTIVATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MFR FACILITY THE DEVICE WAS RUNNING WITHOUT USER ACTIVATION WHEN THE CABLE WAS FLEXED. NO PT 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
    1 MICRO OSCILLATING SAW HBE STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK