BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FW,BPB #2 SUTR,BLU W/NDL

    MDR report key: 10666727 · Received October 12, 2020

    Report

    Report Number
    1220246-2020-02225
    Event Type
    Injury
    Date Received
    October 12, 2020
    Date of Event
    September 18, 2020
    Report Date
    October 12, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    GAT
    UDI-DI
    00888867041264
    PMA / PMN Number
    K122374
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THREE FIBERWIRES, AR-7200, BROKE DURING THE INSERTION OF A BIO-SCREW. ALL SUTURE FRAGMENTS WERE RETRIEVED FROM THE PATIENT AND DISCARDED. THE CASE WAS COMPLETED WITH NO ADVERSE EFFECT TO THE PATIENT. ADDITIONAL INFORMATION PROVIDED (B)(6) 2020: THE BROKEN END END OF THE FINAL CONSTRUCT IS IMPLANTED WITH THE SCREWS. ADDITIONAL INFORMATION PROVIDED (B)(6) 2020: THERE WERE A TOTAL OF 3 SUTURES USED CONSECUTIVELY AND ALL 3 SNAPPED AT ONE END. FOR THE FIRST 2 SUTURES USED, THE SURGEON REMOVED THEM WHEN THEY SNAPPED BUT FOR THE THIRD SUTURE, THE SURGEON LEFT IT IMPLANTED IN THE BONE WITH THE SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1125013 FW,BPB #2 SUTR,BLU W/NDL SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ARTHREX, INC. FW,BPB #2 SUTR,BLU W/NDL 21944 00888867041264

    Patients

    Seq Age Sex Outcome Treatment
    1 Other