BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOLUBE-III

    MDR report key: 3963952 · Received December 13, 2013

    Report

    Report Number
    1045834-2013-14828
    Event Type
    Malfunction
    Date Received
    December 13, 2013
    Date of Event
    January 27, 2011
    Report Date
    January 31, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GEY
    PMA / PMN Number
    K970530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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 ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) RETURNING THE DEVICE FOR SERVICE. DURING SERVICE, HOSE DAMAGED WAS FOUND. THE DEVICE WAS USED DURING SURGERY. NO PT OR USER INJURY REPORTED. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652941 AUTOLUBE-III GEY DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1