BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED REAMER SLEEVE, 10°

    MDR report key: 19949270 · Received August 9, 2024

    Report

    Report Number
    1220246-2024-07118
    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-9597-10, BATCH 37622247 WAS RECEIVED FOR INVESTIGATION. THE REAMER WAS RECEIVED WITH THE MATING PART AR-9676 BATCH 022338 INSIDE, HOWEVER THE DEVICE WAS NOT STUCK. SCRATCH LINES WERE ALSO NOTED ON THE COLLAR OF THE AR-9597-10. WHEN THE DEVICE UNDERGOES FUNCTIONAL TESTING WITHIN THE AR-9676 BATCH 022338, 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 07/24/2024, 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
    2174629 ANGLED REAMER SLEEVE, 10° MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. ANGLED REAMER SLEEVE, 10° 37622247 00888867343436

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown