BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBERLOCK SUSPENSION SYSTEM

    MDR report key: 19488212 · Received June 7, 2024

    Report

    Report Number
    1220246-2024-05317
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    April 19, 2023
    Report Date
    June 7, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    UDI-DI
    00888867377875
    PMA / PMN Number
    K172612
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED OFF THE INFORMATION PROVIDED, 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 4/21/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT THE DX FIBERTAK FROM AN AR-8988-CP FIBERLOCK SUSPENSION SYSTEM WOULD NOT SEAT. THE SURGEON FOLLOWED ALL THE TECHNIQUES CORRECTLY, DRILLED ACCORDINGLY, FOLLOWED THE LASER LINES, AND USED X-RAY FOR VISUALIZATION; HOWEVER, WHEN INSERTING THE DX FIBERTAK, STEP FOUR OF THE GUIDE, THE ANCHOR MET RESISTANCE AND WAS UNABLE TO ADVANCE PAST THE SECOND CORTEX. THE SURGEON CHANGED HAND POSITION AND TAPPED LIGHTLY, BUT THE FIBERTAK COULD NOT ENTIRELY BE INSERTED AND COULD ONLY BREACH A BIT OF THE SECOND CORTEX. ANOTHER AR-8988-CP FIBERLOCK SUSPENSION SYSTEM KIT WAS OPENED, AND THE SURGEON USED THE DX SWIVELOCK INSTEAD OF THE DX FIBERTAK TO COMPLETE THE PROCEDURE SUCCESSFULLY. THIS WAS DISCOVERED DURING A CMC SUSPENSIONPLASTY PROCEDURE ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1011933 FIBERLOCK SUSPENSION SYSTEM NON-DEGRADABLE FIXATN FASTENER MBI ARTHREX, INC. FIBERLOCK SUSPENSION SYSTEM 15068481 00888867377875

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown