BEUDAMED
    FDA Adverse Event Injury Summary report: N

    H/W INTERNALBRACE LGMNT AUGMNT REPR KIT

    MDR report key: 13225998 · Received January 11, 2022

    Report

    Report Number
    1220246-2022-04285
    Event Type
    Injury
    Date Received
    January 11, 2022
    Date of Event
    December 23, 2021
    Report Date
    January 11, 2022
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    UDI-DI
    00888867286801
    PMA / PMN Number
    K101823
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    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. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8990ST-2 DX FIBERTAK WAS INSERTED THROUGH A 1.6MM PREPARED BONE TUNNEL AND AFTER IT PASSED THROUGH THE CORTEX, IT WAS DISCOVERED THAT THE FORKS ON THE INSERTER DEVICE HAD SHREDDED THE SUTURES BUNDLE. THIS WAS DISCOVERED DURING A REVISION OF A FAILED CMC INTERNAL BRACE ON (B)(6) 22021. SURGEON REDIRECTED TUNNELS AND USED A SINGLE-LOADED FIBERTAK DX TO COMPLETE PROCEDURE. ADDITIONAL INFORMATION RECEIVED 12/23/2021. THERE WERE NOT ARTHREX DEVICES EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1094024 H/W INTERNALBRACE LGMNT AUGMNT REPR KIT FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE MBI ARTHREX, INC. H/W INTERNALBRACE LGMNT AUGMNT REPR KIT 12921527 00888867286801

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other