BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED REAMER, DRIVE SHAFT

    MDR report key: 22850324 · Received August 20, 2025

    Report

    Report Number
    1220246-2025-03547
    Event Type
    Malfunction
    Date Received
    August 20, 2025
    Date of Event
    August 4, 2025
    Report Date
    October 7, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867324954
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. ONE UNPACKAGED AR-9676, ANGLED REAMER, DRIVE SHAFT, BATCH 022339, WAS RECEIVED FOR INVESTIGATION. - VISUAL EVALUATION OF THE RETURNED DEVICE NOTED THAT IT WAS STUCK INSIDE AN AR-9597-20 REAMER SLEEVE, BATCH 37622112. - FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE OF THE DEVICES. - THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE DUE TO A FORCE PERPENDICULAR TO THE DRIVE SHAFT BEING APPLIED WHILE THE DEVICE IS SPINNING. THIS APPLIED FORCE CREATES AN EXCESS OF FRICTION AND HEAT THAT ULTIMATELY HAS THE POTENTIAL TO CAUSE THE DEVICE TO CEASE FUNCTIONING AS INTENDED. APPLICATION OF THIS FORCE PERPENDICULAR TO THE DRIVE SHAFT IS NOT NEEDED FOR THE DEVICE TO FUNCTION, NOR IS IT RECOMMENDED THAT THE USER DO THIS DURING NORMAL CLINICAL USE. WHEN USED USUALLY, THIS ISSUE IS UNLIKELY TO PRESENT ITSELF, WHICH SUGGESTS THAT THE HANDLING OF THE DEVICE GREATLY IMPACTS WHETHER OR NOT IT WILL SEIZE. FOR THIS REASON, THE DIRECT CAUSE IS CONSIDERED TO BE DEVICE MISUSE. - REFER TO INVESTIGATION PHOTOS. - COMPLAINT ALLEGATION IS CONFIRMED.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA SEMS-07008221 THAT AN AR-9597-20 ANGLED REAMER SLEEVE, AND AN AR-9676 ANGLED REAMER COLD WELDED TOGETHER. THIS OCCURRED DURING A CASE, THEY WERE ABLE TO PULL THEM APART, BUT THEY ARE NOW BENT AND WILL NOT FIT TOGETHER PROPERLY THERE WERE NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1244685 ANGLED REAMER, DRIVE SHAFT MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. ANGLED REAMER, DRIVE SHAFT 022339 00888867324954

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown