BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED REAMER SLEEVE, 20°

    MDR report key: 21776395 · Received April 4, 2025

    Report

    Report Number
    1220246-2025-01246
    Event Type
    Malfunction
    Date Received
    April 4, 2025
    Date of Event
    March 17, 2025
    Report Date
    May 22, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. THE COMPLAINT ALLEGATION WAS CONFIRMED. ONE UNPACKAGED AR-9597-20, SERIAL/BATCH NUMBER (B)(6), WAS RECEIVED FOR INVESTIGATION. THE VISUAL EVALUATION REVEALED HEAVY SCRATCHES AND LINES IN THE SLEEVE COLLAR AND SCRATCHES ALONG THE SHAFT. BOTH DEVICES ARRIVED SEPARATELY FOR INVESTIGATION. THE OBSERVED CONDITION IS MOST LIKELY THE RESULT OF HEAVY USE. VISUAL EVALUATION REVEALED HEAVY SCRATCHES AND LINES IN THE SLEEVE COLLAR. BECAUSE THE MATTING HAD HEAVY SCRATCHES ALONG THE DEVICE'S OD, IT IS POSSIBLE THAT THE INSTRUMENT WILL BIND TOGETHER WHEN THE METAL IS TOO HOT TO RUN FOR A LONG TIME. FUNCTIONAL TESTING WAS PERFORMED BY INSERTING THE AR-9676 BATCH 022338 INSIDE THE AR-9597-20 BATCH 37622051, RESISTANCE WAS FELT WHEN TRYING TO ROTATE. THE OBSERVED CONDITION IS MOST LIKELY CAUSED BY OVERHEATING DURING USE, WHICH CAN BE ATTRIBUTED TO THE AGE OR EXTENSIVE USE OF THE DEVICE. 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 (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9597-20 REAMER SLEEVE AND AN AR-9676 DRIVER SHAFT ARE BROKEN. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2334590 ANGLED REAMER SLEEVE, 20° MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. ANGLED REAMER SLEEVE, 20° N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown