BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK GII QUICK ANCHOR

    MDR report key: 59690 · Received December 26, 1996

    Report

    Report Number
    1221934-1996-00006
    Event Type
    Malfunction
    Date Received
    December 26, 1996
    Date of Event
    October 17, 1996
    Report Date
    October 23, 1996
    Manufacturer
    MITEK PRODUCTS
    Product Code
    KGS
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    DURING A MODIFIED BANKART PROCEDURE, LEFT SHOULDER CO CAT# 212393 SUTURE BROKE WHILE ATTEMPTING TO INSERT. ALL PIECES WERE RETRIEVED AND NEW DEVICE USED TO COMPLETE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITEK GII QUICK ANCHOR SUTURE ANCHOR KGS MITEK PRODUCTS NA 960656

    Patients

    Seq Age Sex Outcome Treatment
    1