BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONIC OBTR,FOR 4MM SCOPE SHTH

    MDR report key: 19391821 · Received May 24, 2024

    Report

    Report Number
    1220246-2024-03844
    Event Type
    Malfunction
    Date Received
    May 24, 2024
    Date of Event
    August 13, 2021
    Report Date
    May 24, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    NBH
    UDI-DI
    00888867101616
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. COMPLAINT CONFIRMED. ONE UNPACKAGED AR-3375-4011, BATCH 1903546 WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION IDENTIFIED THAT THE DEVICE IDENTIFIERS WERE WORN/FADED, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO IMPROPER DETERGENT/CLEANING PROCESS USED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE IS PITTING CORROSION WITH THIS DEVICE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2333275 CONIC OBTR,FOR 4MM SCOPE SHTH ARTHROSCOPE AND ACCESSORIES NBH ARTHREX, INC. CONIC OBTR,FOR 4MM SCOPE SHTH 1903546 00888867101616

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown