BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED REAMER SLEEVE, 10°

    MDR report key: 17577106 · Received August 18, 2023

    Report

    Report Number
    1220246-2023-07572
    Event Type
    Malfunction
    Date Received
    August 18, 2023
    Date of Event
    July 18, 2023
    Report Date
    November 6, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867343436
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    501

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS CONFIRMED. ONE UNPACKAGED AR-9597-10 SERIAL/BATCH NUMBER (B)(6) WAS RECEIVED FOR INVESTIGATION. FUNCTIONAL TESTING WITH THE RETURNED MATING PART AR-9676, BATCH 022028 FOUND RESISTANCE AND FRICTION WHEN THE ANGLE REAMER WAS ATTEMPTED TO PUT INSIDE THE ANGLE REAMER SLEEVE. THE VISUAL EVALUATION REVEALED HEAVY SCRATCHES AND LINES IN THE SLEEVE COLLAR. MULTIPLE DENTS WERE OBSERVED ALONG THE SHAFT CLOSE TO THE LASER ETCHING. BOTH DEVICES ARRIVE SEPARATELY FOR INVESTIGATION. THE MOST LIKELY CAUSE(S) FOR THE REPORTED FAILURE IS THE WEAR AND TEAR DAMAGE INCURRED OVER REPEATED USAGE.

    Description of Event or Problem · 0

    ON 7/20/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9676 ANGLED REAMER, DRIVE SHAFT, AND AN AR-9597-10 ANGLED REAMER SLEEVE HAD AN ISSUE AND GOT STUCK TOGETHER. THIS HAPPENED DURING A CASE. THEY HAD ANOTHER SET THAT WAS USED TO COMPLETE THE PROCEDURE. THIS OCCURRED DURING USE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 8/10/2023, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: THIS OCCURRED DURING A REVERSE PROCEDURE ON (B)(6) 2023. WHEN THE INSTRUMENTS GOT STUCK TOGETHER, THIS OCCURRED OUTSIDE THE PATIENT, AND NO PIECE BROKE OFF. THE BONE QUALITY OF THE PATIENT WAS NOT PROVIDED, AND THERE WAS NO CASE DELAY AS THEY HAD ANOTHER SET THERE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2167878 ANGLED REAMER SLEEVE, 10° MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. ANGLED REAMER SLEEVE, 10° 37622112 00888867343436

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown