BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH DEVICE, 2.7 / 3.5 / 4.0MM, LOW PRO

    MDR report key: 21294941 · Received February 3, 2025

    Report

    Report Number
    1220246-2025-00144
    Event Type
    Malfunction
    Date Received
    February 3, 2025
    Date of Event
    December 23, 2024
    Report Date
    June 2, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTJ
    UDI-DI
    00888867052253
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-8943-15 LOW PROFILE DEPTH DEVICE BATCH NUMBER: 012351 WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION OF THE RETURNED DEVICE NOTED THAT THE SLIDER PIN OF THE DEPTH DEVICE HAD DISASSEMBLED AT THE WELD FROM THE SLIDER BODY. FUNCTIONAL TESTING WAS NOT ABLE TO BE PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO WEAR AND TEAR INCURRED FROM REPEATED USAGE/REPROCESSING. REFER TO INVESTIGATION PHOTOS.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PATELLA FRACTURE SURGERY THE NARROW "STICK" HAS BROKEN OFF. THE BROKEN PIECE WAS RECEIVED OUT OF THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1294014 DEPTH DEVICE, 2.7 / 3.5 / 4.0MM, LOW PRO DEPTH GAUGE HTJ ARTHREX, INC. DEPTH DEVICE, 2.7 / 3.5 / 4.0MM, LOW PRO 012351 00888867052253

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown