BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHREX INC SCORPION MULTIFIRE NEEDLE

    MDR report key: 7876492 · Received September 13, 2018

    Report

    Report Number
    MW5079808
    Event Type
    Malfunction
    Date Received
    September 13, 2018
    Date of Event
    September 12, 2018
    Report Date
    September 12, 2018
    Manufacturer
    ARTHREX INC.
    Product Code
    GAB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A (B)(6) Y/O FEMALE WAS ADMITTED FOR OUTPATIENT PROCEDURE FOR RIGHT SHOULDER ARTHROSCOPY / ROTATOR CUFF REPAIR / SUBACROMIAL DECOMPRESSION. DURING RIGHT ARTHROSCOPIC SHOULDER REPAIR, THE DISTAL 2 - 1 1/2 MM OF THE "SCORPION" NEEDLE TIP BROKE OFF IN PT. AN XRAY WAS OBTAINED AND THE NEEDLE TIP WAS NOTED IN PT'S JOINT. SURGEON ATTEMPTED TO LOCATE THE TIP IN PT'S JOINT AND WAS UNSUCCESSFUL. POST PROCEDURE, THE PT WAS STABLE AND TAKEN TO RECOVERY ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714772 ARTHREX INC SCORPION MULTIFIRE NEEDLE NEEDLE, SUTURING, DISPOSABLE GAB ARTHREX INC. SCORPION 10220742

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other