BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED REAMER SLEEVE, 20°

    MDR report key: 18032608 · Received October 30, 2023

    Report

    Report Number
    1220246-2023-08458
    Event Type
    Malfunction
    Date Received
    October 30, 2023
    Date of Event
    October 4, 2023
    Report Date
    August 23, 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

    THE COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-9597-20, SERIAL/BATCH NUMBER (B)(6), WAS RECEIVED FOR INVESTIGATION. THE VISUAL EVALUATION REVEALED HEAVY SCRATCHES AND LINES IN THE SLEEVE COLLAR. SCRATCHES WERE OBSERVED ALONG THE SHAFT. BOTH DEVICES ARRIVE SEPARATELY FOR INVESTIGATION. THE OBSERVED CONDITION IS MOST LIKELY DUE TO HEAVY USE. FUNCTIONAL TESTING WAS CONDUCTED WITH THE RECEIVED MATING PART AR-9676, BATCH 022304. WHEN ATTEMPTING TO INSERT THE SHAFT INTO THE AR-9597-20, RESISTANCE WAS ENCOUNTERED, PREVENTING A PROPER FIT. THE OBSERVED CONDITION IS MOST LIKELY CAUSED BY OVERHEATING DURING USE, WHICH CAN BE ATTRIBUTED TO THE AGE OR EXTENSIVE USE OF THE DEVICE.

    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-9676 ANGLED REAMER, DRIVE SHAFT, AND AN AR-9597-20 ANGLED REAMER SLEEVE HAD AN ISSUE DURING A RTSA PROCEDURE ON (B)(6) 2023. WHILE REAMING THE GLENOID, THE ANGLED REAMER DRIVER SHAFT SLOWLY WELDED TOGETHER WITH THE ANGLED REAMER SLEEVE. THIS CAUSED THE SURGEON'S WRIST TO SUDDENLY TWIST AND MADE THE REAMING DIFFICULT. THE CASE CARRIED ON AND WAS COMPLETED SUCCESSFULLY. THIS OCCURRED DURING USE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 10/17/2023, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: WHEN THE COMPLAINT DEVICES HAD WELDED TOGETHER, BACKUP INSTRUMENTS WERE USED FOR THE REMAINDER OF THE CASE. THE SURGEON DID NOT OBTAIN ANY INJURY WHEN HIS WRIST TWISTED. THERE WAS NO CASE DELAY REPORTED. THE PATIENT HAD GOOD BONE QUALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1927679 ANGLED REAMER SLEEVE, 20° MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. ANGLED REAMER SLEEVE, 20° UNK 00888867343450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown