BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE SHOULDER INSTR

    MDR report key: 2173503 · Received July 23, 2011

    Report

    Report Number
    1219602-2011-00118
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    May 4, 2011
    Report Date
    June 20, 2011
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY
    Product Code
    NBH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PART OF THE CUTTING EDGE IS BROKEN AND WAS RETURNED, IT APPEARS TO HAVE SNAPPED, ADDITIONAL INFORMATION WAS REQUESTED AS TO THE TYPE OF SUTURE AND HOW MANY LEGS OF SUTURE WERE BEING CUT, THE TIP IS BENT AND THE DEVICE WAS TESTED WITH ULTRABRAID SUTURE AND THE DEVICE DID NOT CUT. (B)(4)

    Description of Event or Problem · 1

    THE TIP OF THE CUTTER BROKE OFF; PER MALFUNCTION REPORT THE PIECE WAS REMOVED BY OPENING THE SHOULDER. RETURN OF THE DEVICE SHOWED THAT PART OF THE CUTTING EDGE IS BROKEN AND IT APPEARS TO HAVE SNAPPED, ADDITIONAL INFORMATION WAS REQUESTED AS TO THE TYPE OF SUTURE AND HOW MANY LEGS OF SUTURE WERE BEING CUT, THE TIP IS BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELITE SHOULDER INSTR SUTURE CUTTER NBH SMITH & NEPHEW ENDOSCOPY 72202589 2181

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention