BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISCOVERY

    MDR report key: 2101710 · Received May 23, 2011

    Report

    Report Number
    2101710
    Event Type
    Injury
    Date Received
    May 23, 2011
    Date of Event
    May 22, 2011
    Report Date
    May 23, 2011
    Manufacturer
    BIOMET
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    IT WAS DETERMINED THAT A SMALL METAL TAB (1CM) BROKE OFF OF THE BIOMET DISCOVERY BEARING ROTATION TOOL (CATALOG NUMBER 414952) WHILE IT WAS BEING USED BY THE SURGEON AS HE WAS ATTEMPTING TO CHANGE THE POLYETHYLENE ULNAR COMPONENT ON IMPLANT. SURGEON WAS UNABLE TO PROCEED WITH THE SURGERY DUE TO THE BROKEN ROTATION TOOL. THE ATTEMPT TO USE THE BROKEN INSTRUMENT RESULTED IN DAMAGE TO THE IMPLANT (ULNA BEARING REVISION KIT - DISCOVERY CATALOG NUMBER 114800). PATIENT TO RETURN TO SURGERY IN THE FUTURE FOR COMPLETION OF PROCEDURE. THE BIOMET REP INDICATED THAT HE HAD NOTIFIED THE COMPANY AND REQUESTED A REPLACEMENT FOR THE BROKEN INSTRUMENT. HE SAID THAT HE THOUGHT THEY WOULD PROVIDE A "MODIFIED" INSTRUMENT AS A REPLACEMENT. ALSO HE SAID THAT HE HAD NEVER SEEN THIS HAPPEN BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISCOVERY BEARING ROTATION TOOL LXH BIOMET 414952 293910

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R