BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBERTAK

    MDR report key: 19453145 · Received June 3, 2024

    Report

    Report Number
    1220246-2024-04780
    Event Type
    Malfunction
    Date Received
    June 3, 2024
    Date of Event
    November 2, 2021
    Report Date
    June 3, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    UDI-DI
    00888867292123
    PMA / PMN Number
    K130458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 IMPROPER BONE PREP AND/OR MISALIGNED INSERTION. AS NO FURTHER INVESTIGATION WAS ABLE TO BE PERFORMED NO CHANGE IN HARM WAS IDENTIFIED. COMPLAINT TRENDING FOR THIS EVENT WILL BE PERFORMED PER (B)(4).

    Description of Event or Problem · 0

    ON 11/2/2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3638 KNOTLESS FIBERTAK ANCHOR, AFTER HITTING IT WITH A MALLET, DID NOT SEAT IN NEAR CORTEX. DESPITE THE SURGEON MULTIPLE ATTEMPTS, ANCHOR WOULD NOT SEAT. THIS WAS DISCOVERED DURING A LABRUM REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2319414 FIBERTAK NON-DEGRADABLE FIXATN FASTENER MBI ARTHREX, INC. FIBERTAK 13948187 00888867292123

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown