BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH DEVICE, 2.0 / 2.4MM

    MDR report key: 18140585 · Received November 15, 2023

    Report

    Report Number
    1220246-2023-08749
    Event Type
    Malfunction
    Date Received
    November 15, 2023
    Date of Event
    October 18, 2023
    Report Date
    October 25, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    UDI-DI
    00888867312807
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    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. MANUFACTURED DATE 2019.

    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.

    Description of Event or Problem · 0

    ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN AR-18700-27 DEPTH DEVICE AND AN AR-18700-35 DEPTH DEVICE WERE DEFECTIVE; BOTH DEVICES WOULD STICK WHEN ATTEMPTING TO READ DEPTH AND MAKING IT DIFFICULT FOR THE SURGEON TO GET AN ACCURATE READING. THE CASE WAS COMPLETED UTILIZING THE DEPTH GAUGE FROM THE 2.4/3.0 CFS SET. THIS HAS OCCURRED IN PREVIOUS CASES. THIS WAS DISCOVERED DURING AN METACARPAL FRACTURE PROCEDURE ON 10/18/2023, WITH NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286615 DEPTH DEVICE, 2.0 / 2.4MM MANUAL INSTR, GENERAL SURGICAL MDM ARTHREX, INC. DEPTH DEVICE, 2.0 / 2.4MM 051914 00888867312807

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown