BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOLUBE-III WITH IRRIGATION

    MDR report key: 3242843 · Received July 23, 2013

    Report

    Report Number
    1045834-2013-03590
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    September 6, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY (B)(4). RELIABILITY ENGINEERING EVALUATED THE DEVICE, AND THE REPORTED PROBLEM COULD NOT BE CONFIRMED. THE UNIT WAS TESTED AND FOUND TO MEET ALL SPECIFICATIONS AND PERFORMED AS DESIGNED WITH NO PROBLEMS NOTED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) STATING THAT THE DEVICE'S "HANDLE IS STIFF AND DOES NOT RETURN TO ORIGINAL PLACE." IT IS UNKNOWN IF DEVICE WAS BEING USED DURING SURGERY. IT IS UNKNOWN IF INJURY OR MEDICAL INTERVENTION OCCURRED. THE DATE OF THE EVENT IS UNKNOWN. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343751 AUTOLUBE-III WITH IRRIGATION MOTOR, SURGICAL INSTRUMENT, AC-POWERED - FOOT CONTROL GEY DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1