BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE ANCHOR, BIO-CORKSCREW FT

    MDR report key: 7112014 · Received December 13, 2017

    Report

    Report Number
    1220246-2017-00469
    Event Type
    Injury
    Date Received
    December 13, 2017
    Date of Event
    November 16, 2017
    Report Date
    December 13, 2017
    Manufacturer
    ARTHREX INC.
    Product Code
    MAI
    UDI-DI
    00888867023352
    PMA / PMN Number
    K082810
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. THIS IS ONE OF TWO SUBMISSIONS ASSOCIATED WITH THIS SINGLE EVENT. THE OTHER IS CC130728-LINE 213263-00470. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. COMPLAINT CONFIRMED. THE EVALUATION REVEALED THAT THE ANCHOR BROKE-OFF DIAGONALLY AT THE DISTAL THREAD. THE THREADS ARE SLIGHTLY DEFORMED AND SHOW SIGNS OF GOUGING MARKS. COMPLAINANT'S EVENT IS TYPICALLY CAUSED BY NOT INSERTING THE IMPLANT CO-AXIAL TO THE BONE TUNNEL OR PRYING/LEVERAGING THE DRIVER WHILE THE IMPLANT IS STILL LOADED. 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 THE DEVICE IS RETURNED AND ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CUFF REPAIR THE SURGEON IMPLANTED THE ANCHORS. THREE DEVICES BROKE {LINE 214260 - LOT. 10048632 & LINE 214263 LOT. 10132102}. THE SURGEON HAD TO MODIFY THE POSITION OF THE IMPLANTS SO HE NEEDED TO MAKE ADDITIONAL HOLES INSIDE THE HUMERUS. FOLLOW-UP INVESTIGATION: THE TIP OF THE BROKEN ANCHORS ALREADY BURIED REMAINED IN THE PATIENT, IN THE BONE. THE SURGEON REMOVED THE FREE FRAGMENTS VISIBLE IN THE JOINT ONLY ONE SCREW WILL BE RETURNED, THE OTHER 2 WERE DISCARDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893822 SUTURE ANCHOR, BIO-CORKSCREW FT FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX INC. 10048632 00888867023352

    Patients

    Seq Age Sex Outcome Treatment
    1 Other