BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE PASS SHUTTLE NEEDLE, BOX OF 5

    MDR report key: 1082898 · Received July 25, 2008

    Report

    Report Number
    1219602-2008-00168
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 27, 2008
    Report Date
    June 27, 2008
    Manufacturer
    SMITH & NEPHEW INC., ENDOSCOPY DIV.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ONE OF THE TIPS BROKE OFF WHEN SURGEON WAS PASSING SUTURE THROUGH THE CUFF. THEN THE SURGEON USED 2 MORE NEEDLES AND THE TIPS BROKE OFF AS WELL. SURGEON WAS ABLE TO RETRIEVE TWO OF THE TIPS FROM THE PT BUT ONE TIP STILL REMAINED IN THE PT. THE SURGERY WAS COMPLETED BY USING AN ARTHROPIERCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELITE PASS SHUTTLE NEEDLE, BOX OF 5 JACK NEEDLE FMI SMITH & NEPHEW INC., ENDOSCOPY DIV. 7210693 50245330

    Patients

    Seq Age Sex Outcome Treatment
    1