BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED REAMER SLEEVE, 10°

    MDR report key: 18161902 · Received November 17, 2023

    Report

    Report Number
    1220246-2023-08786
    Event Type
    Malfunction
    Date Received
    November 17, 2023
    Date of Event
    October 24, 2023
    Report Date
    January 31, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867343436
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT IS CONFIRMED. VISUAL EVALUATION NOTED THAT AR-9597-10 HAD DAMAGE ON THE EDGES AROUND THE DEVICE AND ABRASION MARKS ON THE BASE OF THE ANGLED REAMER. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DEVICES AR-9597-10 AND AR-9676 HAVE BEEN RECEIVED STUCK. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO INTERFERENCE WITH THE MATING INSTRUMENT.

    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.

    Description of Event or Problem · 0

    ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9597-10 ANGLED REAMER SLEEVE STARTED BIDING UP AND GOT STUCK TOGETHER ALONG WITH AN AR-9676 ANGLED REAMER, DRIVER SHAFT, AND AN AR-9241-03 GLENOID INSERTER/IMPACTOR HAD A PIECE OF THE BLUE PLASTIC BREAK DURING THE CASE. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THE CASE WAS COMPLETED SUCCESSFULLY BY USING THE SAME PRODUCTS AGAIN BY OPENING A NEW TRAY. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION RECEIVED ON 10/27/2023: THIS WAS DISCOVERED DURING A REVERSE SHOULDER PROCEDURE ON (B)(6) 2023. THERE WAS A DELAY OF A COUPLE OF MINUTES TO OPEN ANOTHER TRAY WITH NO ADDITIONAL ANESTHESIA ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880276 ANGLED REAMER SLEEVE, 10° MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. ANGLED REAMER SLEEVE, 10° 37622112 00888867343436

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown