BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE PASS

    MDR report key: 3874014 · Received May 22, 2014

    Report

    Report Number
    3874014
    Event Type
    Malfunction
    Date Received
    May 22, 2014
    Date of Event
    May 14, 2012
    Report Date
    May 22, 2014
    Manufacturer
    SMITH & NEPHEW
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THE TIP OF THE NEEDLE BROKE OFF DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305714 ELITE PASS ARTHROSCOPIC SUTURE PASSER HRX SMITH & NEPHEW * 50494353

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR NO OTHER THERAPIES