BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED REAMER SLEEVE, 20°

    MDR report key: 19212861 · Received April 30, 2024

    Report

    Report Number
    1220246-2024-02615
    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
    00888867343450
    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-9597-20 ANGLED REAMER SLEEVE BATCH NUMBER: 37622043 WAS RECEIVED FOR INVESTIGATION. THE MATING PART AR-9676 BATCH NUMBER: 022339 WAS RECEIVED SEPARATELY FROM THE ANGLED REAMER SLEEVE. UPON VISUAL INVESTIGATION, IT WAS NOTED THAT THE AR-9597-20 HAD WEAR AND TEAR AND SCRATCHES ON THE SLEEVE COLLAR AS WELL AS IN THE INTERNAL DIAMETER AREA ON THE DISTAL SIDE. FUNCTIONAL TESTING WAS PERFORMED WITH THE AR-9676 BATCH NUMBER: 022339 AND IT WAS NOTED THAT THE MATING PART WAS MET WITH FRICTION AND WAS NOT ABLE TO SMOOTHLY ATTACH AND DETACH. THIS FAILURE CAN BE ASSUMED TO BE RELATED TO THE REPORTED FAILURE. A MOST LIKELY CAUSE FOR THE FAILURES FOUND 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 04/02/2024 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
    146502 ANGLED REAMER SLEEVE, 20° MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. ANGLED REAMER SLEEVE, 20° 37622043 00888867343450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown