BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED REAMER SLEEVE, 10°

    MDR report key: 19447429 · Received June 3, 2024

    Report

    Report Number
    1220246-2024-04708
    Event Type
    Malfunction
    Date Received
    June 3, 2024
    Date of Event
    May 6, 2024
    Report Date
    September 19, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867343436
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-9676, BATCH 022304 WAS RECEIVED FOR INVESTIGATION. THE VISUAL EVALUATION REVEALED HEAVY SCRATCHES AND LINES IN THE OUTSIDE DIAMETER. SCRATCHES WERE OBSERVED ALONG THE SHAFT. BOTH DEVICES ARRIVE SEPARATELY FOR INVESTIGATION. THE OBSERVED CONDITION IS MOST LIKELY DUE TO HEAVY USE. DURING THE FUNCTIONAL TESTING WITH THE AR-9597-20 PART FROM BATCH 37622232, RESISTANCE WAS ENCOUNTERED WHEN TRYING TO INSERT THE SHAFT OF THE AR-9676, WHICH PREVENTED A PROPER FIT. THE OBSERVED CONDITION IS MOST LIKELY CAUSED BY OVERHEATING DURING USE, WHICH CAN BE ATTRIBUTED TO THE AGE OR EXTENSIVE USE OF THE DEVICE.

    Description of Event or Problem · 0

    ON 5/6/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 2) OF AN AR-9676 ANGLED REAMER, DRIVE SHAFT WAS GETTING STUCK INSIDE AN AR-9597-20 ANGLED REAMER SLEEVE, 20° AND AN AR-9597-10 ANGLED REAMER SLEEVE, 10°. ANOTHER DEVICE WAS SWAPPED, AND THE CASE WAS COMPLETED WITHOUT ADVERSE EFFECTS ON THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO INDIVIDUAL CASE INFORMATION PROVIDED AND NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1940846 ANGLED REAMER SLEEVE, 10° MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. ANGLED REAMER SLEEVE, 10° 3762227 00888867343436

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown