BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYS 7 HIGH SPEED PRECISION SAW

    MDR report key: 2933296 · Received January 29, 2013

    Report

    Report Number
    0001811755-2013-00098
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE SERVICE INSPECTION A SAMPLE WAS TAKEN. ALTHOUGH THERE WAS NO EVIDENCE OF ACTIVE LEAKING FOUND, THE PRESENCE OF A SUBSTANCE THAT MAY HAVE EMITTED FROM THE HANDPIECE IS LIKELY TO BE CAUSED OR CONTRIBUTED TO BY FLUID INSIDE OF THE DEVICE. ACCORDING TO A REVIEW OF RISK DOCUMENTATION AND BASED ON PREVIOUS COMPLAINTS WITH SIMILAR EVENT DESCRIPTIONS, A POSSIBLE CAUSE OF THIS FAILURE IS NOT SUFFICIENTLY DRYING THE HANDPIECE AFTER THE WASH CYCLE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR EVALUATION; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE SYSTEM 7 HIGH SPEED PRECISION SAW WAS SENT FOR EVALUATION DUE TO LEAKING AN UNKNOWN SUBSTANCE DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Description of Event or Problem · 1

    THE SYSTEM 7 HIGH SPEED PRECISION SAW WAS SENT FOR EVALUATION DUE TO LEAKING AN UNKNOWN SUBSTANCE DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39739 SYS 7 HIGH SPEED PRECISION SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1