BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOUBLE LOADED KNOTLESS FIBERTAK, KNEE

    MDR report key: 18996722 · Received March 28, 2024

    Report

    Report Number
    1220246-2024-01691
    Event Type
    Malfunction
    Date Received
    March 28, 2024
    Date of Event
    March 12, 2024
    Report Date
    June 6, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    UDI-DI
    00888867428041
    PMA / PMN Number
    K230568
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. 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 03/12/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3740SP DOUBLE LOADED KNOTLESS KNEE FIBERTAK ANCHOR, SELF-PUNCHING 2.6 MM, VE5 ANCHOR DID NOT DEPLOY AND PULLED OUT. THIS WAS DISCOVERED DURING A CASE. ADDITIONAL INFORMATION RECEIVED ON 3/18/2024: THIS WAS DISCOVERED DURING A LATERAL EXTRA ARTICULAR TENODESIS PROCEDURE. THE CASE WAS COMPLETED BY USING A METAL STAPLE. SINCE THE AR-3740SP KNOTLESS KNEE FIBERTAK WAS REMOVED AND THE STAPLES WERE IMPLANTED, THE CASE WAS DELAYED BETWEEN FIVE TO TEN MINUTES. ADDITIONAL ANESTHESIA WAS NOT NEEDED AND THE PATIENT SUFFERED NO NEGATIVE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527457 DOUBLE LOADED KNOTLESS FIBERTAK, KNEE NON-DEGRADABLE FIXATN FASTENER MBI ARTHREX, INC. DOUBLE LOADED KNOTLESS FIBERTAK, KNEE 15161795 00888867428041

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown