BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE PASS SHUTTLE NEEDLE, BOX OF 5

    MDR report key: 1003775 · Received February 22, 2008

    Report

    Report Number
    1219602-2008-00041
    Event Type
    Malfunction
    Date Received
    February 22, 2008
    Report Date
    January 29, 2008
    Manufacturer
    SMITH & NEPHEW INC., ENDOSCOPY DIV.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    DURING PASSAGE OF THE SUTURES THROUGH THE TORN ROTATOR CUFF, THE TIP OF THE NEEDLE BROKE. THE NEEDLE TIP WAS NOT VISUALIZED AND APPEARED TO HAVE BROKEN WITHIN THE ROTATOR CUFF TISSUE ITSELF. THE NEEDLE TIP WAS NOT ABLE TO BE VISUALIZED FROM THE SUBACROMIAL OR GLENOHUMERAL SPACE. SURGEON WAS UNABLE TO RETRIEVE THE BROKEN NEEDLE.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1