BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMB SAG SAW

    MDR report key: 2891068 · Received November 14, 2012

    Report

    Report Number
    1811755-2012-04078
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 22, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORROSION WAS DISCOVERED THROUGHOUT THE INTERNAL COMPONENTS OF THE DEVICE, INCLUDING THE MOTOR, WHICH IS A PORTABLE CAUSE OF THE DEVICE RUNNING WITHOUT USER ACTIVATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER FACILITY, THE SAW WAS TRYING TO RUIN 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
    1 REMB SAG SAW HBE STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK