BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 7 SAG SAW

    MDR report key: 3932786 · Received July 14, 2014

    Report

    Report Number
    0001811755-2014-02505
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED RUN-ON WAS CONFIRMED BY A MANUFACTURER REPAIR TECHNICIAN THROUGH FUNCTIONAL EVALUATION. UPON DISASSEMBLY, CORROSION WAS FOUND THROUGHOUT THE TRIGGER ASSEMBLY, WHICH CAN CONTRIBUTE TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE USER FACILITY THE DEVICE RAN WITHOUT USER ACTIVATION AFTER THE TRIGGER WAS RELEASED. NO PATIENT INVOLVEMENT. NO INJURIES OR ADVERSE CONSEQUENCES WERE KNOWN BY THE INITIAL REPORTER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE USER FACILITY THE DEVICE RAN WITHOUT USER ACTIVATION AFTER THE TRIGGER WAS RELEASED. NO PATIENT INVOLVEMENT. NO INJURIES OR ADVERSE CONSEQUENCES WERE KNOWN BY THE INITIAL REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409628 SYSTEM 7 SAG SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1