BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH DEVICE, 1.4 / 1.6MM

    MDR report key: 18528336 · Received January 17, 2024

    Report

    Report Number
    1220246-2024-00369
    Event Type
    Malfunction
    Date Received
    January 17, 2024
    Date of Event
    December 20, 2023
    Report Date
    January 3, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    UDI-DI
    00888867313835
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. COMPLAINT ALLEGATION IS NOT CONFIRMED. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE OF THIS FAILURE IS ATTRIBUTED TO WEAR AND TEAR DAMAGE INCURRED OVER REPEATED USAGE.

    Description of Event or Problem · 0

    ON 12/20/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT THE DEPTH DEVICES, AR-18700-27 AND AR-18700-35. ARE NOT READING ACCURATELY AND NOT SLIDING. OCCURRED DURING A CASE WITH NO ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403570 DEPTH DEVICE, 1.4 / 1.6MM MANUAL INSTR, GENERAL SURGICAL MDM ARTHREX, INC. DEPTH DEVICE, 1.4 / 1.6MM 051914 00888867313835

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown