BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED REAMER SLEEVE, 10°

    MDR report key: 19141846 · Received April 19, 2024

    Report

    Report Number
    1220246-2024-02151
    Event Type
    Malfunction
    Date Received
    April 19, 2024
    Date of Event
    March 22, 2024
    Report Date
    August 19, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867343436
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    501

    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

    COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED, AR-9597-10, WAS RECEIVED FOR INVESTIGATION. FUNCTIONAL TESTING NOTED THAT THERE WAS RESISTANCE WITH ITS MATING PART, AR-9676, BATCH 022338. VISUAL EVALUATION REVEALED THAT THE DEVICE HAD NICKS AND STRIATION MARKS ON THE BODY. THE MOST LIKELY CAUSE IS ATTRIBUTED TO MISUSE DUE TO INTERFERENCE WITH THE MATING INSTRUMENT.

    Description of Event or Problem · 0

    ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN AR-9597-10 ANGLED REAMER SLEEVE AND AN AR-9676 ANGLED REAMER, DRIVE SHAFT WERE COLD WELDED TOGETHER. THERE WAS NO CASE INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED ON 4/1/2024: THIS WAS DISCOVERED AFTER USE. CASE WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1081280 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