BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM II SOFT TISSUE REPAIR SYSTEM

    MDR report key: 2083012 · Received May 4, 2011

    Report

    Report Number
    MW5020525
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    April 26, 2011
    Report Date
    May 4, 2011
    Manufacturer
    CONMED LINVATEC
    Product Code
    GDG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PER CIRCULATOR'S REPORT, "DURING SHOULDER ARTHROSCOPY, TIP OF SPECTRUM BROKE OFF INSIDE OF SHOULDER. PHYSICIAN LOCATED IT AND REMOVED IT WITHOUT DIFFICULTY." AFTER DISCUSSION WITH STAFF AND THE SALES REP, I LEARNED THIS IS A "LIMITED REUSE STRAIGHT SUTURE HOOK." LIMITED REUSE SUTURE HOOKS ARE NOT TO EXCEED 5 PROCEDURES. IT IS UNK HOW MANY PROCEDURES WERE PERFORMED WITH THIS HOOK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRUM II SOFT TISSUE REPAIR SYSTEM STRAIGHT SUTURE HOOK GDG CONMED LINVATEC SPECTRUM II

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR