BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 22484749 · Received July 11, 2025

    Report

    Report Number
    1220246-2025-02837
    Event Type
    Malfunction
    Date Received
    July 11, 2025
    Date of Event
    June 16, 2025
    Report Date
    September 4, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTJ
    UDI-DI
    00888867052253
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. THE REPORTED EVENT WAS CONFIRMED AS THE EVALUATION OF THE RECEIVED AR-8943-15 WITH BATCH 012445 REVEALED THAT THE INSTRUMENT'S NEEDLE WAS DETACHED AT THE WELD (SEE EVALUATION PICTURE 2). NO FUNCTIONAL TEST WAS PERFORMED FOR THE INSTRUMENT DUE TO THE DAMAGE. THE MOST LIKELY CAUSE IS MISUSE DUE TO USER ERROR OF USING EXCESSIVE FORCE TO PRY AND LEVERAGE THE DEVICE.

    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

    IT WAS REPORTED THAT DURING AN ANKLE JOINT SURGERY THE DEVICE BROKE AT THE WELD SEAM. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    873160 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 012445 00888867052253

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown