BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH DEVICE, 2.7 / 3.5 / 4.0MM, LOW PRO

    MDR report key: 23464890 · Received November 4, 2025

    Report

    Report Number
    1220246-2025-04982
    Event Type
    Malfunction
    Date Received
    November 4, 2025
    Date of Event
    October 24, 2025
    Report Date
    December 31, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTJ
    UDI-DI
    00888867052253
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. THE COMPLAINT ALLEGATION WAS CONFIRMED. ONE UNPACKAGED AR-8943-15 BATCH 012439 WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE NEEDLE WAS DETACHED FROM THE MEASUREMENT GUIDE AT THE WELD. LASER MARKS THAT WERE FADING WERE ALSO NOTED. A FUNCTIONAL TEST CANNOT BE PERFORMED DUE TO THE DAMAGE TO THE DEVICES. THE MOST LIKELY CAUSE OF THE REPORTED AND OBSERVED FAILURE IS WEAR AND TEAR OF THE DEVICE DUE TO PROCESSING AND USE.

    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 10/24/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8943-15 DEPTH DEVICE NECK OF THE DEVICE BROKE OFF FROM THE BASE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2730229 DEPTH DEVICE, 2.7 / 3.5 / 4.0MM, LOW PRO DEPTH GAUGE HTJ ARTHREX, INC. DEPTH DEVICE, 2.7 / 3.5 / 4.0MM, LOW PRO 012439 00888867052253

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown