BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHREX SUREFIRE SCORPION

    MDR report key: 3111730 · Received May 8, 2013

    Report

    Report Number
    MW5030135
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 29, 2013
    Manufacturer
    ARTHREX
    Product Code
    MFJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PT HAD A RETURN ROTATOR CUFF. THE PT WAS GIVEN AN ARTHROSCOPIC REPAIR USING ARTHREX INSTRUMENTS/THE SCORPION WAS USED. THIS DEVICE HAD A DISPOSABLE NEEDLE INSERT. DURING THE REPAIR, ONE OF THE INSERTS BROKE OFF OF THE SCORPION DEVICES. THE SURGEON WAS AWARE. THE SURGEON IS BRINGING THE PT IN FOR X-RAY AND ASSESSMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200062 ARTHREX SUREFIRE SCORPION SCORPION MFJ ARTHREX AR13991N 961926T

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR DEVICE.| DISPOSABLE PRODUCT THAT ATTACHED TO SCORPION