BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHREX, INC

    MDR report key: 2396795 · Received December 29, 2011

    Report

    Report Number
    MW5023657
    Event Type
    Malfunction
    Date Received
    December 29, 2011
    Date of Event
    May 25, 2011
    Report Date
    December 20, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TIP OF DISPOSABLE SCORPION NEEDLE USED TO PASS SUTURE BROKE OFF IN PT WHILE DEVICE IN USE TO REPAIR ROTATOR CUFF. THE SIZE OF THE TIP THAT BROKE OFF WAS ESTIMATED TO BE <1/8TH INCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHREX, INC SURE FIRE SCORPION NEEDLE WITH SURE MITT FMI ARTHREX, INC. AR-13991N 387010

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR