BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SABO SAG SAW

    MDR report key: 3926453 · Received July 10, 2014

    Report

    Report Number
    0001811755-2014-02460
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 13, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED OVERHEATING OF THE DEVICE WAS NOT ABLE TO BE CONFIRMED BY A MANUFACTURER REPAIR TECHNICIAN. UPON DISASSEMBLY FOR VISUAL EXAMINATION, NO COMPONENTS WERE IDENTIFIED WHICH WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED FAILURE. THE DEVICE WAS SERVICED FOR PREVENTIVE MAINTENANCE AND RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, THE DEVICE WAS OVERHEATING. NO INJURIES OR ADVERSE CONSEQUENCES WERE KNOWN BY THE INITIAL REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404118 SABO SAG SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1