BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED REAMER, ORIENTATION HANDLE

    MDR report key: 21890355 · Received April 23, 2025

    Report

    Report Number
    1220246-2025-01661
    Event Type
    Malfunction
    Date Received
    April 23, 2025
    Date of Event
    March 28, 2025
    Report Date
    August 18, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867324947
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    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 NOT CONFIRMED. ONE UNPACKAGED AR-9678 ANGLED REAMER ORIENTATION HANDLE BATCH NUMBER: 052317 WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION OF THE RETURNED DEVICE NOTED NO APPARENT ISSUES WITH THE EXTERIOR OF THE DEVICE. FUNCTIONAL TESTING WAS PERFORMED BY ASSEMBLING THE RETURNED DEVICE WITH THE RETURNED AR-9597-20 ANGLED REAMER SLEEVE AND IT WAS FOUND THAT THE AR-9678 SECURELY LOCKED AND UNLOCKED AS INTENDED WITH THE AR-9597-20. NO PROBLEM FOUND.

    Description of Event or Problem · 0

    ON 03/28/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) THAT AN AR-9597-20 REAMER SLEEVE FUSED INTO THE AR-9678 ORIENTATION HANDLE AND WOULD NOT SPIN. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674370 ANGLED REAMER, ORIENTATION HANDLE MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. ANGLED REAMER, ORIENTATION HANDLE 00888867324947

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown