BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE PASS SHUTTLE NEEDLE, BOX OF 5

    MDR report key: 1001361 · Received February 20, 2008

    Report

    Report Number
    1219602-2008-00039
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Date of Event
    January 23, 2008
    Report Date
    January 24, 2008
    Manufacturer
    SMITH & NEPHEW INC., ENDOSCOPY DIVISION
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SALES REPRESENTATIVE FOR SMITH-NEPHEW IS REPORTING THAT THE SURGEON WAS PERFORMING MULTIPLE ANCHOR SINGLE ROW REVISION RCR PROCEDURE. AFTER A FEW PASSES, SURGICAL ASSISTANT ACTUALLY HIT TIP OF NEEDLE AS IT PASSED THROUGH TENDON TO RELAY SUTURE. SURGEON INSPECTED NEEDLE AND DECIDED TO CONTINUE TO USE FOR FINAL ANCHOR. UPON PASSING FIBERWIRE SUTURE THROUGH TISSUE THE NEEDLE BROKE DISTALLY AND REMAINED TRANS-TENDONOUS. NEEDLE LOCATION WAS CONFIRMED TO BE IN THE MUSCLE BY C-ARM X-RAY. AFTER MULTIPLE ATTEMPTS AND ASSISTANCE BY ANOTHER FELLOWSHIP TRAINED SHOULDER SURGEON, THE NEEDLE WAS LEFT IN THE PATIENT.

    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 DIVISION 7210693 50234889

    Patients

    Seq Age Sex Outcome Treatment
    1