BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED REAMER, DRIVE SHAFT

    MDR report key: 19212693 · Received April 30, 2024

    Report

    Report Number
    1220246-2024-02611
    Event Type
    Malfunction
    Date Received
    April 30, 2024
    Date of Event
    April 3, 2024
    Report Date
    April 30, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867324954
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT WAS CONFIRMED. ONE UNPACKAGED AR-9676 ANGLED REAMER DRIVE SHAFT BATCH NUMBER: 022339 WAS RECEIVED FOR INVESTIGATION. THE MATING PART AR-9597-20 ANGLED REAMER SLEEVE BATCH NUMBER: 37622043 WAS RECEIVED SEPARATELY FROM THE ANGLED REAMER DRIVE SHAFT. UPON VISUAL INVESTIGATION, IT WAS NOTED THAT THE AR-9676 HAD SIGNIFICANT WEAR AND TEAR AND HAD STRIATIONS ALONG BOTH THE DISTAL AND PROXIMAL ENDS OF THE DEVICE. THE HUDSON CONNECTOR OF THE DEVICE ALSO HAD NOTABLE DAMAGE. THE MOST LIKELY CAUSE FOR THE DAMAGE TO THE HUDSON CONNECTOR CAN BE ATTRIBUTED TO MISUSE DUE TO THE DAMAGE TO THE DEVICE. FUNCTIONAL TESTING WAS PERFORMED WITH AN AR-9597-20 ANGLED REAMER SLEEVE BATCH NUMBER: 37622043 AND IT WAS NOTED THAT THE AR-9676 WAS MET WITH FRICTION AND WAS NOT ABLE TO SMOOTHLY ATTACH AND DETACH FROM THE AR-9597-20 ANGLED REAMER SLEEVE. THIS FAILURE CAN BE ASSUMED TO BE RELATED TO THE REPORTED FAILURE. THE MOST LIKELY CAUSE OF THIS FAILURE CAN BE ATTRIBUTED TO WEAR AND TEAR DAMAGE INCURRED OVER REPEATED USAGE. REFER TO INVESTIGATION PHOTOS.

    Description of Event or Problem · 0

    ON 04/03/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9597-20 ANGLED REAMER SLEEVE WELDED WITH THE AR-9676 ANGLED REAMER. THIS OCCURRED DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2024 WHILE REAMING THE DEVICES WELDED TOGETHER, CAUSING THE SURGEON'S WRIST TO SUDDENLY TWIST AND MAKING THE REAMING DIFFICULT. THE CASE CARRIED ON AND WAS COMPLETED SUCCESSFULLY WITH A DIFFERENT REAMER SLEEVE AND DRIVESHAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2080613 ANGLED REAMER, DRIVE SHAFT MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. ANGLED REAMER, DRIVE SHAFT 022339 00888867324954

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown