BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHONDRAL PICK 45 DEGREE

    MDR report key: 1031614 · Received April 18, 2008

    Report

    Report Number
    MW5006302
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    January 28, 2008
    Report Date
    January 28, 2008
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN 2008, DURING ARTHROSCOPIC KNEE PROCEDURE, THE TIP BROKE OFF INSTRUMENT AND FELL INTO THE KNEE JOINT. TIP WAS RETRIEVED BY PHYSICIAN. THIS PRODUCT HAS THE TRADEMARK OF ATLANTECH CE. LOT # 1002/05 AND ETCHED ON THE METAL PICK. LEARNED THAT THIS COMPANY WAS PURCHASED BY ARTHROCARE CORP ACCORDING TO THEIR WEB-SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHONDRAL PICK 45 DEGREE ORTHOPEDIC PRODUCTS LXH ARTHROCARE CORPORATION CHONDRAL PICK 45 DEGREE 02/05

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR