BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED REAMER, DRIVE SHAFT

    MDR report key: 19917469 · Received August 6, 2024

    Report

    Report Number
    1220246-2024-07040
    Event Type
    Malfunction
    Date Received
    August 6, 2024
    Date of Event
    July 17, 2024
    Report Date
    September 10, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867324954
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    THE COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED, AR-9676, BATCH 022338, WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION NOTED SIGNS OF GRINDING ON THE DISTAL AND PROXIMAL END OF THE DEVICE. FUNCTIONAL TESTING WITH A NEW MATING PART, AR-9597-20, NOTED THAT THE REAMER DID NOT MOVE FREELY WITHIN THE SHAFT OF THE AR-9597-20. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE DUE TO INTERFERENCE WITH THE MATING INSTRUMENT.

    Description of Event or Problem · 0

    ON 07/17/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4) THAT AN AR-9597-20 ANGLED REAMER SLEEVE, 20 AND AN AR-9676 ANGLED REAMER, DRIVE SHAFT WAS CEASED AND STUCK AND WERE NOT ABLE TO SPIN ON EACH OTHER. THIS WAS DISCOVERED BEFORE THE CASE, WITH NO CASE INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1770288 ANGLED REAMER, DRIVE SHAFT MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. ANGLED REAMER, DRIVE SHAFT 022338 00888867324954

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown