BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DX FIBERTAK SUTURE ANCHOR, #1 FW & NDLS

    MDR report key: 18817565 · Received March 1, 2024

    Report

    Report Number
    1220246-2024-01244
    Event Type
    Malfunction
    Date Received
    March 1, 2024
    Date of Event
    February 7, 2024
    Report Date
    September 3, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    UDI-DI
    00888867265004
    PMA / PMN Number
    K172612
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6 COMPLAINT ALLEGATION IS CONFIRMED. UPON VISUAL INSPECTION, IT WAS NOTED THAT THE DISTAL END OF THE SHAFT OF THE FIBERTAK¿ DX SUTURE ANCHOR, #1 FW W/NEEDLES, VE5 HAD TWISTED. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE METHOD OF BONE PREPARATION AND THE QUALITY OF THE BONE ENCOUNTERED WERE PROVIDED. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO IMPROPER BONE PREPARATION, MISALIGNED INSERTION, AND PRYING/LEVERAGING THE DEVICE DURING INSERTION.

    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 02/14/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA E-MAIL THAT AN AR-8990 FIBERTAK¿ DX SUTURE ANCHORS INSERTER SHAFT WAS CRUSHED, RESULTING IN POOR INSERTION. THIS OCCURRED DURING A PROCEDURE UPON INSERTING IT INTO THE FIBULA, THE INSERTER SHAFT WAS CRUSHED, RESULTING IN POOR INSERTION. THE BONE WAS PREPPED USING A F1.6MM DRILL INSIDE THE AR-8990DS. THE SURGEON CREATED AN ADDITIONAL BONE HOLE WITH A F1.8MM K WIRE AND INSERTED IT AGAIN. HE WAS ABLE TO INSERT IT WITH LITTLE RESISTANCE, AND TO RECOVER WITHOUT ANY FIXATION PROBLEMS. ADDITIONAL INFORMATION PROVIDED 2/20/24: THE PROCEDURE PERFORMED WAS A ATFL REPAIR. NOTHING BROKE OFF INSIDE OF THE PATIENT. NO IMAGES OR VIDEOS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1919811 DX FIBERTAK SUTURE ANCHOR, #1 FW & NDLS NON-DEGRADABLE FIXATN FASTENER MBI ARTHREX, INC. DX FIBERTAK SUTURE ANCHOR, #1 FW & NDLS 14964189 00888867265004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown