BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH DEVICE, 2.0MM

    MDR report key: 17559553 · Received August 16, 2023

    Report

    Report Number
    1220246-2023-07514
    Event Type
    Malfunction
    Date Received
    August 16, 2023
    Date of Event
    July 18, 2023
    Report Date
    November 6, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867385443
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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

    THE COMPLAINT ALLEGATION WAS CONFIRMED. ONE UNPACKAGED AR-18800-38, SERIAL/BATCH NUMBER (B)(6), WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION OBSERVED THAT THE DEPTH DEVICE SHAFT'S TIP WAS BROKEN OFF. THE MOST PROBABLE CAUSE IS APPLYING EXCESSIVE MECHANICAL FORCES UPON INSERTION/USE.

    Description of Event or Problem · 0

    ON (B)(6), 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-18800-38 DEPTH DEVICE IS BROKEN. THIS OCCURRED DURING A CASE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1828824 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