BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMB SAG SAW

    MDR report key: 2902023 · Received November 26, 2012

    Report

    Report Number
    1811755-2012-04156
    Event Type
    Malfunction
    Date Received
    November 26, 2012
    Date of Event
    October 26, 2012
    Report Date
    October 26, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORROSION WAS DISCOVERED IN THE MOTOR AND PRESS PLUG. PREVENTATIVE MAINTENANCE WAS PERFORMED ON THE BEARINGS.

    Description of Event or Problem · 1

    THE REMB SAG SAW WAS RETURNED FOR SERVICE. UPON EVAL AT THE MFR, IT WAS FOUND TO RUN W/O USER ACTIVATION AT THE MFR, IT WAS FOUND TO RUN W/O USER ACTIVATION. THERE WAS NO PT INVOLVEMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.

    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