BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DX FIBERTAK SUTURE ANCHOR, ST & NDLS

    MDR report key: 19476351 · Received June 6, 2024

    Report

    Report Number
    1220246-2024-05039
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Date of Event
    December 20, 2021
    Report Date
    June 6, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    UDI-DI
    10888867301051
    PMA / PMN Number
    K172612
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. DISCARDED BY FACILITY. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO APPLYING EXCESSIVE MECHANICAL FORCES UPON INSERTION.

    Description of Event or Problem · 0

    ON 12/202/2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (4) AR-8990ST FIBERTAKS PULLED OUT OF IMPLANTATION SITE. THIS WAS DISCOVERED DURING LATERAL ANKLE RECONSTRUCTION PROCEDURE. SURGEON USED AN AR-8990ST FIBERTAKS FROM A DIFFERENT LOT NUMBER TO COMPLETE CASE SUCCESSFULLY WITHOUT FURTHER ISSUES. AFTER RECEIVING ADDITIONAL INFORMATION ON 12/20/2021, SALES REPRESENTATIVE HAS CONFIRMS THAT ONCE THE FIBERTAKS PULLED OUT, SURGEON REMOVED THEM FROM INSIDE THE PATIENT AND NOTHING BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5657 DX FIBERTAK SUTURE ANCHOR, ST & NDLS NON-DEGRADABLE FIXATN FASTENER MBI ARTHREX, INC. DX FIBERTAK SUTURE ANCHOR, ST & NDLS 14524330 10888867301051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown