BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED REAMER SLEEVE, 10°

    MDR report key: 17675044 · Received September 3, 2023

    Report

    Report Number
    1220246-2023-07766
    Event Type
    Malfunction
    Date Received
    September 3, 2023
    Date of Event
    August 7, 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
    NE, 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

    ADDITIONAL INFORMATION: D9, G3, H3, H6. THE COMPLAINT IS CONFIRMED. ONE UNPACKAGED AR-9597-10 SERIAL/BATCH NUMBER (B)(6) WAS RECEIVED FOR INVESTIGATION. FUNCTIONAL TESTING WITH THE RETURNED MATTING PART AR-9676, BATCH 022304 FOUND RESISTANCE AND FRICTION. THE DEVICES DO NOT ROTATE SMOOTHLY. THE VISUAL EVALUATION REVEALED HEAVY SCRATCHES AND LINES IN THE SLEEVE COLLAR. IT WAS OBSERVED A PIECE OF METAL ATTACHED IN THE INSIDE DIAMETER CLOSE TO THE CONNECTOR. 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 08/07/2023, 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, 10° HAD AN ISSUE. THEY WERE WORN OUT AND THE DOCTORS WERE COMPLAINING THAT THEY NEEDED TO BE REPLACED. THIS OCCURRED DURING USE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAD BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2249333 ANGLED REAMER SLEEVE, 10° MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. ANGLED REAMER SLEEVE, 10° UNK 00888867343436

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown