BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED REAMER, DRIVE SHAFT

    MDR report key: 21266472 · Received January 29, 2025

    Report

    Report Number
    1220246-2025-00111
    Event Type
    Malfunction
    Date Received
    January 29, 2025
    Date of Event
    January 6, 2025
    Report Date
    March 14, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867324954
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    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 CONFIRMED. ONE UNPACKAGED AR-9676 ANGLED REAMER DRIVE SHAFT BATCH NUMBER: 022304 WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION OF THE RETURNED DEVICE NOTED DAMAGE TO THE DEVICE WITH STRIATIONS AND DEEP SCRATCHES OBSERVED ON BOTH THE PROXIMAL AND DISTAL END OF THE DEVICE. FUNCTIONAL TESTING WAS PERFORMED BY INSERTING THE RETURNED AR-9676 ANGLED REAMER DRIVE SHAFT TO THE RETURNED AR-9597-20 ANGLED REAMER SLEEVE BATCH: 37622320 AND ITT WAS NOTED THAT THE DEVICE WAS MET WITH FRICTION AND NOT ABLE TO GO INTO THE ANGLED REAMER SLEEVE SMOOTHLY AS INTENDED. 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 SEIZE FROM 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 NORMALLY, THIS ISSUE IS UNLIKELY TO PRESENT ITSELF, WHICH SUGGESTS THAT THE HANDLING OF THE DEVICE HAS A LARGE IMPACT ON WHETHER OR NOT IT WILL SEIZE. FOR THIS REASON, THE DIRECT CAUSE IS CONSIDERED TO BE MISUSE OF THE DEVICE.

    Description of Event or Problem · 0

    ON 01/06/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9676 ANGLED REAMER WAS STUCK INSIDE OF THE AR-9597-20 ANGLED REAMER SLEEVE. THIS OCCURRED DURING A CASE WITH NO EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515386 ANGLED REAMER, DRIVE SHAFT MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. ANGLED REAMER, DRIVE SHAFT 022304 00888867324954

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown