BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANT SYSTEM, FIBERTAK BUTTON

    MDR report key: 19277947 · Received May 9, 2024

    Report

    Report Number
    1220246-2024-03019
    Event Type
    Malfunction
    Date Received
    May 9, 2024
    Date of Event
    September 20, 2021
    Report Date
    May 9, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    UDI-DI
    00888867305441
    PMA / PMN Number
    K191426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. DISCARDED BY FACILITY. THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO EXCESSIVE FORCE USED DURING SUTURE PASSING/TIGHTENING /TENSIONING AND/OR IMPROPER BONE PREP.

    Description of Event or Problem · 0

    ON 09/210/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3680 FIBERTAK IMPLANT SYSTEM, 2ND SHUTTLE STITCH LOCKED AND WOULD NOT ADVANCE. THIS WAS DISCOVERED DURING USE IN A BICEP TENODESIS REPAIR ON (B)(6) 2021. THE SURGEON TUGGED ON THE AR-3680 TO RELEASE THE SUTURE, AND THE ENTIRE IMPLANT CAME OUT. THE CASE WAS COMPLETED BY USING AN AR-2290 PROXIMAL IMPLANT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1358164 IMPLANT SYSTEM, FIBERTAK BUTTON NON-DEGRADABLE FIXATION FASTENER MBI ARTHREX, INC. IMPLANT SYSTEM, FIBERTAK BUTTON 13297008 00888867305441

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown