BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    24MM PRIMARY REAMER

    MDR report key: 19117850 · Received April 16, 2024

    Report

    Report Number
    1220246-2024-02061
    Event Type
    Malfunction
    Date Received
    April 16, 2024
    Date of Event
    April 22, 2022
    Report Date
    April 16, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED OFF THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A MANUFACTURING ISSUE; HOWEVER, DUE TO THE DEVICE NOT BEING RETURNED, WE ARE UNABLE TO CONFIRM THE REPORTED EVENT.

    Description of Event or Problem · 0

    ON 04/22/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-9618-24 REAMER PACKAGING CONTAINED THE WRONG ITEM. THIS WAS DISCOVERED DURING AN UNKNOWN TIME WHEN THE AR-9618-24 PACKAGING HAD A AR-9619-33 INSIDE. THERE WAS NO PATIENT EFFECT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1333774 24MM PRIMARY REAMER ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. 24MM PRIMARY REAMER UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown