BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINVATEC (A CONMED COMPANY)

    MDR report key: 1131183 · Received August 19, 2008

    Report

    Report Number
    1131183
    Event Type
    Malfunction
    Date Received
    August 19, 2008
    Date of Event
    August 5, 2008
    Report Date
    August 15, 2008
    Manufacturer
    LINVATEC CORPORATION
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A RIGHT KNEE ARTHROSCOPY WITH ACL REPAIR THE END OF A RADIUS RESECTOR ABRIDER STARTED TO DISINTEGRATE AND SHAVINGS OF METAL FELL INTO THE OPEN KNEE WOUND. ALL OF THESE INSTRUMENTS WERE IMMEDIATELY TAKEN OUT OF SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINVATEC (A CONMED COMPANY) 5.5 MM FULL RADIUS RESECTOR HRX LINVATEC CORPORATION BBD36484

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPIRATION DATE: 06/01/2010| REPROCESSING INFORMATION FROM THE ASCENT LABEL:| ASCENT LOT# 141527