BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED REAMER SLEEVE, 20°

    MDR report key: 19590365 · Received June 21, 2024

    Report

    Report Number
    1220246-2024-06356
    Event Type
    Malfunction
    Date Received
    June 21, 2024
    Date of Event
    May 28, 2024
    Report Date
    September 18, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867343450
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. THE COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-9597-20, SERIAL/BATCH NUMBER (B)(6), WAS RECEIVED FOR INVESTIGATION. THE VISUAL EVALUATION REVEALED HEAVY SCRATCHES AND LINES IN THE SLEEVE COLLAR AND SCRATCHES ALONG THE SHAFT. BOTH DEVICES ARRIVED SEPARATELY FOR INVESTIGATION. THE OBSERVED CONDITION IS MOST LIKELY DUE TO HEAVY USE. FUNCTIONAL TESTING WAS CONDUCTED WITH THE RECEIVED MATING PART AR-9676, BATCH 022239. WHEN ATTEMPTING TO INSERT THE SHAFT INTO THE AR-9597-20, RESISTANCE WAS ENCOUNTERED, PREVENTING 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.

    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.

    Description of Event or Problem · 0

    ON 05/28/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9676 ANGLED REAMER WAS OFF ANGLE AND CAUGHT THE INSIDE OF THE AR-9597-20 ANGLED REAMER SLEEVE AND BENT IT. THIS OCCURRED DURING A CASE WITH NO EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1183320 ANGLED REAMER SLEEVE, 20° MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. ANGLED REAMER SLEEVE, 20° 37222223 00888867343450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown