BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAARTICULAR TISSUE GRASPER/RONGEUR

    MDR report key: 1264283 · Received December 8, 2008

    Report

    Report Number
    1264283
    Event Type
    Malfunction
    Date Received
    December 8, 2008
    Date of Event
    November 12, 2008
    Report Date
    December 8, 2008
    Manufacturer
    INNOMED, INC.
    Product Code
    HTX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    WHILE USING THE RONGEUR DURING TOTAL HIP REVISION ARTHROPLASTY IT WOULD NOT CLOSE WHILE ATTEMPTING TO GRASP TISSUE, CLOSER INSPECTION REVEALED THAT THE PIN, MEASURING APPROX. 1MM X 4MM ON THE DISTAL END WAS MISSING RENDERING THE INSTRUMENT UNUSABLE. UNABLE TO FIND PIN, AN X-RAY WAS TAKEN AND WAS FOUND NEGATIVE FOR FOREIGN BODY. THE INSTRUMENT WAS REMOVED AND SEQUESTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRAARTICULAR TISSUE GRASPER/RONGEUR RONGEUR, INTRAARTICULAR HTX INNOMED, INC. 1790-02 0905

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR