BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH DEV,2.7/3.5 /4.0MMLO-PRO

    MDR report key: 18738992 · Received February 20, 2024

    Report

    Report Number
    1220246-2024-01035
    Event Type
    Malfunction
    Date Received
    February 20, 2024
    Date of Event
    February 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
    PA, 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. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. COMPLAINT CONFIRMED. ONE UNPACKAGED AR-8943-15 BATCH 012301 WAS RECEIVED FOR EVALUATION. UPON VISUAL INSPECTION, 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 2/1/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT THE SKINNY PART OF AN AR-8943-15 DEPTH DEVICE, THAT SLIDES DOWN TO MEASURE A SCREW BROKE. THIS WAS DISCOVERED DURING A PROCEDURE; THE PATIENT WAS NOT AFFECTED. ADDITIONAL INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465751 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