BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHREX

    MDR report key: 2003536 · Received February 21, 2011

    Report

    Report Number
    MW5019523
    Event Type
    Malfunction
    Date Received
    February 21, 2011
    Date of Event
    January 28, 2011
    Report Date
    February 21, 2011
    Manufacturer
    ARTHREX
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TIP OF NEEDLE BROKE OFF WHILE SUTURING ROTATOR CUFF, UNABLE TO SEE IN WOUND WITH XRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHREX SCORPION NEEDLE LXH ARTHREX AR 13991N 348992

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR