BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    33MM PERIPHERAL REAMER

    MDR report key: 14914617 · Received July 5, 2022

    Report

    Report Number
    1220246-2022-05162
    Event Type
    Malfunction
    Date Received
    July 5, 2022
    Date of Event
    June 13, 2022
    Report Date
    August 31, 2022
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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

    COMPLAINT CONFIRMED. UPON VISUAL INSPECTION, IT WAS NOTED THAT A SPOKE AND A PORTION OF THE REAMER CIRCUMFERENCE WERE BROKEN. THE CAUSE REMAINS UNDETERMINED, HOWEVER A PROBABLE CAUSE CAN BE ATTRIBUTED TO IMPACT WITH ANOTHER DEVICE.

    Description of Event or Problem · 0

    ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9619-33 33 MM PERIPHERAL REAMER BROKE UP WHILE REAMING. ALL BROKEN FRAGMENTS WERE RETRIEVED FROM INSIDE THE PATIENT. THIS WAS DISCOVERED A RTS PROCEDURE ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1449068 33MM PERIPHERAL REAMER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. 33MM PERIPHERAL REAMER 022112

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown