BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOLUBE - III

    MDR report key: 3962878 · Received June 11, 2014

    Report

    Report Number
    1045834-2013-16441
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    September 26, 2011
    Report Date
    September 28, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GEY
    PMA / PMN Number
    K970530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE DEVICE WAS RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE DEVICE WAS EVALUATED, AND DURING SERVICE THE DEVICE WAS FOUND WITH AN AIR LEAK DUE TO A LOOSE HOSE. IF ADD'L INFO BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REF: (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) STATING THAT SERVICE WAS REQUIRED FOR THE DEVICE. DURING SERVICE AN AIR LEAK WAS NOTED. THE DEVICE WAS NOT BEING USED IN SURGERY. IT IS UNK IF INJURY OR MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345093 AUTOLUBE - III SURGICAL SYSTEM FOOT CONTROL GEY DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1