BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DX FIBERTAK SUTURE ANCHOR, #1 FW & NDLS

    MDR report key: 19398296 · Received May 25, 2024

    Report

    Report Number
    1220246-2024-03936
    Event Type
    Malfunction
    Date Received
    May 25, 2024
    Date of Event
    June 24, 2022
    Report Date
    May 25, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    UDI-DI
    00888867265004
    PMA / PMN Number
    K172612
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR DUE TO MISALIGNED INSERTION AND/OR IMPROPER BONE PREPARATION.

    Description of Event or Problem · 0

    ON 6/24/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8990 FIBERTAK DX SUTURE ANCHOR, AFTER USING THE AR-8990DS DRILL KIT AND DRILLING THE BONE SOCKET, THE ANCHOR WOULD NOT DEPLOY NOR ENGAGE IN THE BONE. SURGEON OPENED ANOTHER ANCHOR AND WAS ABLE TO COMPLETE THE CASE WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING AN EXTENSOR CARPI RADIALIS BREVIS REPAIR ON 6/24/2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2304900 DX FIBERTAK SUTURE ANCHOR, #1 FW & NDLS NON-DEGRADABLE FIXATN FASTENER MBI ARTHREX, INC. DX FIBERTAK SUTURE ANCHOR, #1 FW & NDLS 14795475 00888867265004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown