BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUET SUTURE ANCHOR

    MDR report key: 959135 · Received April 30, 2007

    Report

    Report Number
    9613278-2007-00018
    Event Type
    Malfunction
    Date Received
    April 30, 2007
    Date of Event
    March 28, 2007
    Report Date
    March 28, 2007
    Manufacturer
    CONMED LINVATEC BIOMATERIALS LTD
    Product Code
    MAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE NO OTHER COMPLAINTS REFERRING TO THIS SPECIFIC MANUFACTURING LOT. NO INVESTIGATION OF THE DEVICE CAN BE UNDERTAKEN SINCE IT WAS DISPOSED OF BY THE HOSPITAL. A CORRECTIVE ACTION HAS BEEN IMPLEMENTED TO STRENGTHEN THE DUET SUTURE ANCHOR INSTRUCTIONS FOR USE. TARGET DATE FOR THE UPDATED IFU IS END MAY 2007.

    Description of Event or Problem · 1

    IN THE RIGHT ROTATOR CUFF REPAIR, SURGEON USED THE PUNCH TO CREATE A HOLE FOR THE DUET IMPLANT AND THE SCREWED THE IMPLANT IN. THE IMPLANT WAS HALF WAY IN WHEN THE TOP SHEARED OFF. THE SURGEON DID NOT TAP FIRST AS HE FELT IT WAS NOT HARD BONE, AND WAS ABLE TO USE PLIERS TO GRAB THE DUET AND TURN IT BACK OUT. AN ALTERNATE ANCHOR WAS USED OTHER ANCHOR TO FINISH THE PROCEDURE. NO DELAYS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUET SUTURE ANCHOR BIOABSORBABLE SOFT TISSUE FIXATION MAI CONMED LINVATEC BIOMATERIALS LTD * S002683

    Patients

    Seq Age Sex Outcome Treatment
    1