BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED REAMER SLEEVE, 20°

    MDR report key: 19359058 · Received May 21, 2024

    Report

    Report Number
    1220246-2024-03573
    Event Type
    Malfunction
    Date Received
    May 21, 2024
    Date of Event
    October 20, 2022
    Report Date
    May 21, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867343450
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. THE COMPLAINT ALLEGATION WAS CONFIRMED. VISUAL EVALUATION OF THE PICTURES ATTACHED TO THE COMPLAINT OF AN AR-9597-20 ANGLED REAMER SLEEVE, 20° AND AR-9676 REVEALED HEAVY SCRATCHES LINES IN THE SLEEVE COLLAR OF THE MATING PART AR-9676. IT IS CONCLUDED THAT IS THE RESULT OF INTERFERENCE WITH THE MATING INSTRUMENT.

    Description of Event or Problem · 0

    ON 10/21/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9676 DRIVER SHAFT AND AN AR-9597-20 REAMER WERE STUCK TOGETHER. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022. CASE WAS COMPLETED USING A DISPOSABLE REAMER. AFTER THE SURGERY, SALES REPRESENTATIVE EXAMINED THE DEVICES AND REALIZED THEY WERE STUCK. THE DRIVER SHAFT WAS CHUCKED, AND IT STARTED TO ROTATE AND WAS ABLE TO PULL OUT THE SLEEVE CANNULATION. HOWEVER, THE DEVICES NO LONGER MATE SMOOTHLY, AND THE SHAFT CONTINUES TO GET STUCK IN THE SLEEVE. ADDITIONAL INFORMATION RECEIVED ON 10/21/2022: THIS WAS DISCOVERED DURING A TOTAL SHOULDER ARTHROPLASTY PROCEDURE. NOTHING BROKE INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1616913 ANGLED REAMER SLEEVE, 20° MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. ANGLED REAMER SLEEVE, 20° 37622112 00888867343450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown