BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCORPION - SUREFIRE NEEDLE

    MDR report key: 1308783 · Received February 2, 2009

    Report

    Report Number
    1308783
    Event Type
    Malfunction
    Date Received
    February 2, 2009
    Date of Event
    January 23, 2009
    Report Date
    February 2, 2009
    Manufacturer
    ARTHREX ARTHROSCOPY INSTRUMENTS, INC.
    Product Code
    NBH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR OF THE LEFT SHOULDER, THE PROCEDURE TIPS OF THE SCORPION NEEDLE (2 PIECES) BROKE OFF IN THE SHOULDER WHILE GOING THROUGH TISSUE. THE TIPS WERE BOTH APPROXIMATELY 3.0 MM EACH. THE SURGEON WAS UNABLE TO LOCATE THEM. A POST-OP X-RAY SHOWED BOTH PIECES IN THE SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPION - SUREFIRE NEEDLE NEEDLE, SUTURE NBH ARTHREX ARTHROSCOPY INSTRUMENTS, INC. AR-13991N 170421
    2 SCORPION - SUREFIRE NEEDLE NEEDLE, SUTURE NBH ARTHREX ARTHROSCOPY INSTRUMENTS, INC. AR-13991N 170421

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR