BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED REAMER, DRIVE SHAFT

    MDR report key: 19141836 · Received April 19, 2024

    Report

    Report Number
    1220246-2024-02150
    Event Type
    Malfunction
    Date Received
    April 19, 2024
    Date of Event
    March 22, 2024
    Report Date
    June 28, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867324954
    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 IS CONFIRMED. ONE UNPACKAGED AR-9676/BATCH 022338 WAS RECEIVED FOR INVESTIGATION. UPON VISUAL INVESTIGATION, THERE WERE ABRASION MARKS AROUND THE SHAFT OF THE REAMER. FUNCTIONAL TESTING REVEALS THAT THE DEVICE DID NOT ROTATE FREELY DUE TO THE DEEP MARKS AROUND IT. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO INTERFERENCE WITH THE MATING INSTRUMENT.

    Description of Event or Problem · 0

    ON 3/25/2024, 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 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
    1081270 ANGLED REAMER, DRIVE SHAFT MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. ANGLED REAMER, DRIVE SHAFT 022338 00888867324954

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown