BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOLUBE-III

    MDR report key: 3182614 · Received June 21, 2013

    Report

    Report Number
    1045834-2013-02586
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    April 21, 2011
    Report Date
    September 1, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GEY
    PMA / PMN Number
    K970530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS STILL IN PROCESS. WHEN THE INVESTIGATION HAS BEEN COMPLETED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6), STATING THAT THE DEVICE HAD AN OIL LEAK. IT IS KNOWN THAT THE DEVICE WAS NOT USED IN SURGERY. IT IS UNKNOWN IF INJURIES OR MEDICAL INTERVENTION WERE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282764 AUTOLUBE-III MOTOR, SURGICAL INSTRUMENT, AC-POWERED - FOOT CONTROL GEY DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1