BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DILATOR, 5.1 X 210MM

    MDR report key: 20818877 · Received December 2, 2024

    Report

    Report Number
    1220246-2024-08682
    Event Type
    Malfunction
    Date Received
    December 2, 2024
    Date of Event
    October 11, 2024
    Report Date
    August 13, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HNW
    UDI-DI
    00888867462038
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    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 WEAR AND TEAR.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    ON 10/11/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-S6524-041-220, AR-S6524-051-210, AR-S6524-060-200, AND AR-S6524-071-190 DILATOR IS CHIPPED AND BENT AFTER REPEATED USE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333891 DILATOR, 5.1 X 210MM DILATOR HNW ARTHREX, INC. DILATOR, 5.1 X 210MM 01583196 00888867462038

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown