BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIZE 10 LEG, GLENOID TARGETER

    MDR report key: 19459161 · Received June 4, 2024

    Report

    Report Number
    1220246-2024-04833
    Event Type
    Malfunction
    Date Received
    June 4, 2024
    Date of Event
    November 17, 2022
    Report Date
    June 4, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    UDI-DI
    00888867315372
    PMA / PMN Number
    K222007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    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. COMPLAINT IS CONFIRMED. ONE UNPACKAGED AR-5400-10, BATCH NUMBER 052027, WAS RECEIVED FOR INVESTIGATION. FUNCTIONAL TESTING FOUND THAT THE GLENOID TARGETED LEG GETS STUCK WHEN TRYING TO FIT IN THE SLOT. VISUAL EVALUATION FOUND THE DEVICE IS BENT AND HAS MANY GOUGES ALONG THE SHAFT. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR DUE TO USER-APPLIED EXCESSIVE MECHANICAL FORCES. HOWEVER, DUE TO THE DEVICE BEING RETURNED UNPACKAGED, WE ARE UNABLE TO CONFIRM THE REPORTED EVENT.

    Description of Event or Problem · 0

    ON 11/17/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-5400-10 GLENOID TARGETER THE SIZE 10 LEG JAMMED INTO LETTER D'S SLOT ON THE GLENOID TARGETER SHAFT. OTHER SIZED LEGS WERE ABLE TO SLIDE IN AND OUT FREELY OF LETTER D'S SLOT ON THE GLENOID TARGETER SHAFT. THIS OCCURRED AT THE BEGINNING OF A REVERSE TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2022 SO THE 11 LEG WAS SUBSTITUTED IN AND THE CASE CARRIED ON SUCCESSFULLY. THERE WAS NO PATIENT EFFECT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658808 SIZE 10 LEG, GLENOID TARGETER PROSTHESIS, SHOULDER, CEMENTED KWS ARTHREX, INC. SIZE 10 LEG, GLENOID TARGETER 052027 00888867315372

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown