BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH DEVICE, 2.0MM

    MDR report key: 19162522 · Received April 23, 2024

    Report

    Report Number
    1220246-2024-02228
    Event Type
    Malfunction
    Date Received
    April 23, 2024
    Date of Event
    March 27, 2024
    Report Date
    January 6, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867385443
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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

    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 FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER-APPLIED EXCESSIVE MECHANICAL FORCES.

    Description of Event or Problem · 0

    ON 3/27/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-18800-38 DEPTH DEVICE PROBE HOOK SNAPPED OFF EASILY. THIS WAS DISCOVERED DURING THE CASE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942796 DEPTH DEVICE, 2.0MM ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. DEPTH DEVICE, 2.0MM 052215 00888867385443

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown