BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED REAMER, DRIVE SHAFT

    MDR report key: 19949152 · Received August 9, 2024

    Report

    Report Number
    1220246-2024-07117
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    July 24, 2024
    Report Date
    September 27, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867343436
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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

    COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-9676, BATCH 022338, WAS RECEIVED FOR INVESTIGATION. THE REAMER ARRIVED CONTAINED WITHIN THE AR-9597-10, BUT IT WAS NOT LODGED INSIDE. UPON VISUAL INSPECTION, SCRATCH MARKS WERE OBSERVED AT BOTH THE DISTAL AND PROXIMAL ENDS OF THE DEVICE, SUGGESTING SIGNS OF FRICTION. WHEN THE DEVICE UNDERGOES FUNCTIONAL TESTING WITHIN THE AR-9597-10, IT EXPERIENCES RESISTANCE AND FRICTION. THE OBSERVED CONDITION IS MOST LIKELY THE RESULT OF OVERHEATING DURING USE CAUSED BY OVERSTRESSING A DEVICE THAT IS DAMAGED NATURALLY AND INEVITABLY AS A RESULT OF NORMAL WEAR OR AGING.

    Description of Event or Problem · 0

    ON (B)((6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9597-10 ANGLED REAMER SLEEVE AND AN AR-9676 ANGLED REAMER, DRIVE SHAFT WERE DIFFICULT TO TAKE APART FROM ONE ANOTHER WHEN THE AUGMENT TRAY WAS BEING PUT UP AFTER SURGERY AND SEEMS THE INNER SHAFT HAS SCUFF MARKS NOT TO ROTATE PROPERLY. NO ADVERSE EVENT OR ADDED TIME TO THE CASE. THIS WAS DISCOVERED AFTER USE, WITH NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2492197 ANGLED REAMER, DRIVE SHAFT MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. ANGLED REAMER, DRIVE SHAFT 022338 00888867343436

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown