BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21326174 · Received February 6, 2025

    Report

    Report Number
    1220246-2025-00283
    Event Type
    Malfunction
    Date Received
    February 6, 2025
    Date of Event
    January 10, 2025
    Report Date
    April 1, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTJ
    UDI-DI
    00888867052253
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-8943-15, BATCH 012351, WAS RECEIVED FOR EVALUATION. UPON VISUAL INSPECTION, IT WAS NOTED THAT THE DEVICE WAS RETURNED DISASSEMBLED. IT WAS NOTED THAT THE INSTRUMENT'S NEEDLE WAS DETACHED AT THE WELD. 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

    ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8943-15 DEPTH DEVICE HAD THE PROBE ON THE END OF THE DEPTH GAUGE FALL OUT OF WHERE IT GETS WELDED. IT SEEMED THAT THERE WAS VERY LITTLE WELDING AND NOT THE PROPER AMOUNT TO HOLD THE PROBE ON. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 01/23/2025: THE DEVICE BROKE WHILE THE SURGEON WAS ABOUT TO MEASURE THE DRILLED SOCKET. THE SURGEON COMPLETED THE CASE USING THE DEPTH GAUGE WITH THE SAME PART NUMBER FROM ANOTHER SET. THERE WAS NO CASE DELAY, AND IT IS UNKNOWN IF ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION WITH BACKUP FIXATION UTILIZING THE CORTICAL FIXATION SET ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1531109 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 012351 00888867052253

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown