BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NANO CORKSCREW FT, TI, W 3-0 FW

    MDR report key: 19255786 · Received May 6, 2024

    Report

    Report Number
    1220246-2024-02857
    Event Type
    Malfunction
    Date Received
    May 6, 2024
    Date of Event
    September 9, 2021
    Report Date
    May 6, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    UDI-DI
    00888867276703
    PMA / PMN Number
    K180118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 IS CONFIRMED. DEVICE WAS RECEIVED: AR-1317FT BATCH 11576495, PACKAGED. OBSERVATION REVEALED THAT THE IMPLANT ON THE TIP OF THE DEVICE WAS SEPARATED FROM THE TIP INSIDE THE PACKAGE. THE CAUSE OF THIS EVENT IS RELATED TO NCR-09986.

    Description of Event or Problem · 0

    ON 9/9/2021 IT WAS REPORTED BY SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1317FT SUTURE ANCHOR, NANO CORKSCREW® FT, TI, W 3-0 F WAS MISSING ANCHOR FROM THE INSERTER. THIS WAS DISCOVERED DURING A PROCEDURE BUT PACKAGE WAS NEVER OPENED OR USED ON PATIENT. ADDITIONAL INFORMATION RECEIVED 9/9/2021 DEVICE WAS NO NEEDED IN THE CASE AND WILL BE RETURNED TO OUR FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522635 NANO CORKSCREW FT, TI, W 3-0 FW NON-DEGRADABLE FIXATN FASTENER MBI ARTHREX, INC. NANO CORKSCREW FT, TI, W 3-0 FW 11576495 00888867276703

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown