BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO SAGGITAL SAW

    MDR report key: 2920231 · Received December 17, 2012

    Report

    Report Number
    1811755-2012-04296
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 19, 2012
    Manufacturer
    STRYKER INSTRUMENTS
    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

    CORROSION WAS DISCOVERED IN THE SOCKETS, MOTOR, AND PRESS PLUG.

    Description of Event or Problem · 1

    THE MICRO SAGITTAL SAW WAS RETURNED FOR SERVICE. UPON EVALUATION AT THE MANUFACTURER, IT WAS FOUND TO RUN WITHOUT USER ACTIVATION. THERE WAS NO PATIENT INVOLVEMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO SAGGITAL SAW HBE STRYKER INSTRUMENTS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK