BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOLUBE-III WITH IRRIGATION

    MDR report key: 3811276 · Received October 11, 2013

    Report

    Report Number
    1045834-2013-13997
    Event Type
    Malfunction
    Date Received
    October 11, 2013
    Report Date
    June 8, 2011
    Product Code
    GEY
    PMA / PMN Number
    K970530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM THE USA STATED THE DEVICE HAD "EXCESSIVE FOREIGN DEBRIS." IT IS UNKNOWN IF THE DEVICE WAS USED IN SURGERY. IT IS UNKNOWN IF INJURY OR MEDICAL INTERVENTION WERE REPORTED. THE DATE OF THE EVENT IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523867 AUTOLUBE-III WITH IRRIGATION MOTOR, SURGICAL, INSTRUMENT, AC-POWERED - FOOT CONTROL GEY

    Patients

    Seq Age Sex Outcome Treatment
    1