BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANT SYSTEM, FIBERTAK BUTTON

    MDR report key: 19528170 · Received June 13, 2024

    Report

    Report Number
    1220246-2024-05674
    Event Type
    Malfunction
    Date Received
    June 13, 2024
    Date of Event
    April 27, 2021
    Report Date
    June 13, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    UDI-DI
    00888867305441
    PMA / PMN Number
    K191426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    501

    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 COMPLAINT ALLEGATION CANNOT BE CONFIRMED WITHOUT THE DEVICE FOR EVALUATION. THE DEVICE WAS NOT RECEIVED FOR EVALUATION, AND NO PHOTOS OF THE FAILURE WERE PROVIDED. PER THE EVENT DESCRIPTION, THE MOST LIKELY CAUSE(S) OF THE REPORTED FAILURE IS USER ERROR FOLLOWING THE DEVICE SURGICAL TECHNIQUE. ACCORDING TO DFU-0222-6 AT REVISION 0. D. WARNING. PRE-OPERATIVE AND OPERATING PROCEDURES, INCLUDING KNOWLEDGE OF SURGICAL TECHNIQUES AND PROPER SELECTION AND PLACEMENT OF THE DEVICE, ARE IMPORTANT CONSIDERATIONS IN THE SUCCESSFUL UTILIZATION OF THIS DEVICE. THE APPROPRIATE ARTHREX DELIVERY SYSTEM IS REQUIRED FOR PROPER IMPLANTATION OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE, THE AR-3680 DID NOT DEPLOY. A 2ND IMPLANT WAS USED AND THE SURGEON DRILLED DEEPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780182 IMPLANT SYSTEM, FIBERTAK BUTTON NON-DEGRADABLE FIXATN FASTENER MBI ARTHREX, INC. IMPLANT SYSTEM, FIBERTAK BUTTON 12914888 00888867305441

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown