BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED REAMER, DRIVE SHAFT

    MDR report key: 21819229 · Received April 10, 2025

    Report

    Report Number
    1220246-2025-01361
    Event Type
    Malfunction
    Date Received
    April 10, 2025
    Date of Event
    March 20, 2025
    Report Date
    May 7, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. ONE UNPACKAGED AR-9676 ANGLED REAMER DRIVESHAFT BATCH NUMBER: 022338 WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION OF THE RETURNED DEVICE NOTED DAMAGE TO THE DEVICE WITH SCRATCHES AND STRIATIONS OBSERVED ON THE SURFACE, PARTICULARLY ALONG THE DISTAL AND PROXIMAL ENDS OF THE DEVICE. FUNCTIONAL TESTING WAS PERFORMED BY INSERTING THE RETURNED DEVICE INTO THE RETURNED MATING AR-9597-10 ANGLED REAMER SLEEVE BATCH NUMBER: 37622247 AND IT WAS FOUND TO BE MET WITH FRICTION AND RESISTANCE. 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 DOES 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. COMPLAINT ALLEGATION IS CONFIRMED.

    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 03/20/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4) THAT AN AR-9597-10 ANGLED REAMER SLEEVE AND AR-9676 ANGLED REAMER DRIVE SHAFT ARE STUCK TOGETHER. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. CASE WAS DELAYED BY 15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1727047 ANGLED REAMER, DRIVE SHAFT MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. ANGLED REAMER, DRIVE SHAFT 022338

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown