BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED REAMER SLEEVE, 20°

    MDR report key: 20613012 · Received November 5, 2024

    Report

    Report Number
    1220246-2024-08416
    Event Type
    Malfunction
    Date Received
    November 5, 2024
    Date of Event
    October 23, 2024
    Report Date
    February 4, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867343450
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. THE COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-9597-20, SERIAL/BATCH NUMBER (B)(6), WAS RECEIVED FOR INVESTIGATION. THE DEVICE ARRIVED SEPARATED FROM THE AR-9676 BATCH 022338 FOR EVALUATION. THE VISUAL EVALUATION REVEALED HEAVY SCRATCHES AND LINES AT THE COLLAR AND AT THE DISTAL END. FUNCTIONAL TESTING WAS CONDUCTED WITH THE RECEIVED MATING PARTS AR-9676, BATCH 022338. IT WAS NOTED THAT WHEN ATTEMPTING TO INSERT THE SHAFT INTO THE AR-9597-20, RESISTANCE WAS ENCOUNTERED, WHICH PREVENTED A PROPER FIT. ECO-41381 WAS IMPLEMENTED. THE CHANGES BEING IMPLEMENTED ARE DUE TO A PRODUCT IMPROVEMENT INITIATIVE TO ADDRESS COMPLAINTS RELATED TO THE AR-9676 DRIVE SHAFT SEIZING/BINDING DURING USE NCR-27796 WAS OPENED TO ADDRESS THE ISSUE OF THE PARTS BINDING/STICKING TOGETHER.

    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 10/23/2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS-06693573 THAT AN AR-9676 ANGLED REAMER, AND AN AR-9597-20 ANGLED REAMER SLEEVE COLD WELDED TOGETHER. THIS OCCURRED DURING A CASE THAT WAS COMPLETED USING NEW DEVICES. THIS RESULTED IN A 30-MINUTE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2132673 ANGLED REAMER SLEEVE, 20° MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. ANGLED REAMER SLEEVE, 20° 37622246 00888867343450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown