BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIN SET, UNIVERS II/ ECLIPSE

    MDR report key: 19173330 · Received April 24, 2024

    Report

    Report Number
    1220246-2024-02312
    Event Type
    Malfunction
    Date Received
    April 24, 2024
    Date of Event
    May 19, 2021
    Report Date
    April 24, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    UDI-DI
    00888867137493
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 CONFIRMED, EVEN THOUGH THE DEVICE WAS NOT RETURNED, ONE OF THE FIVE SEALED DEVICE THAT WAS RETURNED WAS MEASURED. THE DEVICE MEASURED .114 IN AND MET THE SPECIFICATIONS OF C4481 REV. 6 IT WAS MADE TO. AN ECO HAS BEEN RELEASED SUBSEQUENTLY TO DECREASE THE UPPER TOLERANCE RANGE AND DECREASE THE OPPORTUNITY OF INTERFERENCE WITH THE MATING PART.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A SHOULDER CASE THE PIN WAS STUCK INSIDE THE CUT GUIDE. WHEN THE GUIDE WAS REMOVED THE PIN CAME OUT. THE CASE WAS COMPLETED WITH NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1083708 PIN SET, UNIVERS II/ ECLIPSE MANUAL INSTR, GENERAL SURGICAL MDM ARTHREX, INC. PIN SET, UNIVERS II/ ECLIPSE 11864615 00888867137493

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown