BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DILATOR, 5.1 X 210MM

    MDR report key: 19907594 · Received August 5, 2024

    Report

    Report Number
    1220246-2024-07029
    Event Type
    Malfunction
    Date Received
    August 5, 2024
    Date of Event
    June 26, 2024
    Report Date
    June 19, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HNW
    UDI-DI
    00888867462038
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    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 MISUSE/MISHANDLING DUE TO DAMAGE TO THE DEVICE.

    Description of Event or Problem · 0

    ON 07/09/2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-S6524-051-210 DILATOR HAD A PIECE OF METAL FROM THE INNER CANNULATION THAT STOPPED IT FROM GOING OVER THE SECOND SEQUENTIAL DILATOR. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT AND THE CASE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING AN ENDOSCOPIC DISCECTOMY PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2273868 DILATOR, 5.1 X 210MM DILATOR HNW ARTHREX, INC. DILATOR, 5.1 X 210MM UNK 00888867462038

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown