BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    24MM PRIMARY REAMER

    MDR report key: 21206971 · Received January 22, 2025

    Report

    Report Number
    1220246-2025-00024
    Event Type
    Malfunction
    Date Received
    January 22, 2025
    Date of Event
    December 23, 2024
    Report Date
    March 20, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867298330
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    501

    Narratives

    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 2019.

    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

    ON 12/23/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 6) OF AN AR-9618-24 PRIMARY REAMERS HAD GROWN DULL. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572679 24MM PRIMARY REAMER ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. 24MM PRIMARY REAMER 021921 00888867298330

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown