BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.5MM BIOCOMPOSITE CORK- SCREW FT W2#2 TIGERTAIL

    MDR report key: 2190049 · Received August 4, 2011

    Report

    Report Number
    1220246-2011-00119
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 12, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K082810
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE WAS RECEIVED AND AN EVALUATION WAS CONDUCTED. THE COMPLAINT WAS CONFIRMED. THE EVALUATION REVEALED THE DISTAL SQUARE DRIVE TO BE TWISTED AND DEFORMED AND DETACHED FROM THE MAIN DRIVER SHAFT. MATERIAL ANALYSIS CONFIRMED CORRECT MATERIAL TYPE. AN EXACT AND DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED NOR WAS THIS FAILURE ABLE TO BE DUPLICATED IN A LAB SETTING. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF DRIVER BROKE OFF IN THE IMPLANT. PART OF IMPLANT WITH THE TIP WAS REMOVED; PARTIAL REMAINS IN THE PATIENT. NO MORE IMPLANTS WERE USED. PROCEDURE WAS DELAMINATION OF THE ROTATOR CUFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.5MM BIOCOMPOSITE CORK- SCREW FT W2#2 TIGERTAIL FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. 419470

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other