BEUDAMED
    FDA Adverse Event Other Summary report: N

    ELITE PASS SUTURE SHUTTLE NEEDLE

    MDR report key: 1510228 · Received October 14, 2009

    Report

    Report Number
    MW5013011
    Event Type
    Other
    Date Received
    October 14, 2009
    Date of Event
    September 3, 2009
    Report Date
    September 23, 2009
    Manufacturer
    SMITH AND NEPHEW, INC., ENDOSCOPY
    Product Code
    GAB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE PERFORMED: RIGHT SHOULDER ARTHROSCOPY, EXTENSIVE INTRA-ARTICULAR DEBRIDEMENT, REPAIR OF SUPRA SPINATUS TENDON, SUBACROMIAL DECOMPRESSION, ACROMIOPLASTY AND MUMFORD. ELITE PASS SUTURE SHUTTLE NEEDLE TIP BROKE OFF IN PT'S SHOULDER DURING THE PROCEDURE AND WAS NOT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELITE PASS SUTURE SHUTTLE NEEDLE NONE GAB SMITH AND NEPHEW, INC., ENDOSCOPY 7210693 50291066

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other