BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 879010 · Received June 15, 2007

    Report

    Report Number
    879010
    Event Type
    Malfunction
    Date Received
    June 15, 2007
    Date of Event
    June 7, 2007
    Report Date
    June 15, 2007
    Manufacturer
    ARTHREX ARTHROSCOPY INSTRUMENTS, INC.
    Product Code
    NBH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    AT CANNULA'S INSERTION INTO THE PATIENT'S RIGHT SHOULDER IT WAS NOTED ON CAMERA THAT A SMALL PIECE OF THE CANNULA HAD BROKEN OFF THE END OF THE CANNULA. THE PIECE WAS REMOVED FROM THE PATIENT IN ITS ENTIRETY AND THE CANNULA WAS THEN REMOVED FROM THE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * CANNULA NBH ARTHREX ARTHROSCOPY INSTRUMENTS, INC. * 704713160

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR