BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    24MM PRIMARY REAMER

    MDR report key: 21265539 · Received January 29, 2025

    Report

    Report Number
    1220246-2025-00108
    Event Type
    Malfunction
    Date Received
    January 29, 2025
    Date of Event
    January 6, 2025
    Report Date
    February 28, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867298330
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED, AR-9618-24, 24 MM PRIMARY REAMER, SERIAL/BATCH NUMBER (B)(6), WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION NOTED THAT THE CUTTING BLADES WERE DULL AND NICKED. ADDITIONALLY, THE LASER MARKS WERE FADED. THE MOST LIKELY REASON FOR THE REPORTED FAILURE IS THE WEAR AND TEAR DAMAGE INCURRED OVER REPEATED USAGE. THE MANUFACTURING DATE IS 2022.

    Description of Event or Problem · 0

    ON 01/06/2025 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 3) OF AN AR-9618-24 PRIMARY REAMER INSTRUMENTS WERE DULL AND INEFFECTIVE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892862 24MM PRIMARY REAMER ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. 24MM PRIMARY REAMER 022237 00888867298330

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown