BEUDAMED
    FDA Adverse Event Other Summary report: N

    EASY-OUT

    MDR report key: 1083577 · Received July 24, 2008

    Report

    Report Number
    1220246-2008-00139
    Event Type
    Other
    Date Received
    July 24, 2008
    Date of Event
    June 26, 2008
    Report Date
    June 27, 2008
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED AND THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE CAUSE OF THIS EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE EASY-OUT DEVICE BROKE OFF DURING A REVISION PROCEDURE TO AN ANTERIOR CRUCIATE LIGAMENT REPAIR PERFORMED SEVERAL YEARS AGO. THE SURGEON HAD DECIDED TO USE THE EASY-OUT DEVICE TO ATTEMPT TO REMOVE A COMPETITOR'S TITANIUM SCREW THAT WAS STRIPPED. THE TIP OF THE EASY-OUT BROKE OFF AND REMAINS INSIDE THE TITANIUM SCREW THAT COULD NOT BE REMOVED FROM THE PT. THE SURGEON WAS ABLE TO COMPLETE THE REVISION SUCCESSFULLY AND NO ADD'L ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASY-OUT EASY-OUT LXH ARTHREX, INC. NA 02081404

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other