BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH DEV,2.7/3.5 /4.0MMLO-PRO

    MDR report key: 18923516 · Received March 18, 2024

    Report

    Report Number
    1220246-2024-01533
    Event Type
    Malfunction
    Date Received
    March 18, 2024
    Date of Event
    March 1, 2024
    Report Date
    December 5, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTJ
    UDI-DI
    00888867052253
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED. ONE UNPACKAGED AR-8943-15 BATCH 012301 WAS RECEIVED FOR EVALUATION. UPON VISUAL INSPECTION, IT WAS NOTED THAT THE INSTRUMENT WAS 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.

    Description of Event or Problem · 0

    ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06502306 THAT AN AR-8943-15 DEPTH DEVICE PIN CAME APART FROM THE MEASUREMENT HANDLE. THIS WAS DISCOVERED DURING AN ANKLE FRACTURE REPAIR PROCEDURE ON (B)(6) 2024. THE DEVICE DID NOT BREAK INSIDE THE PATIENT. THE CASE WAS COMPLETED BY REINSERTING THE DEPTH PIN INTO THE HANDLE AND REMEASURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162477 DEPTH DEV,2.7/3.5 /4.0MMLO-PRO DEPTH GAUGE HTJ ARTHREX, INC. DEPTH DEV,2.7/3.5 /4.0MMLO-PRO 012301 00888867052253

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown