BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-COMPRESSION CANN DILATOR TAP, 16MM

    MDR report key: 19212921 · Received April 30, 2024

    Report

    Report Number
    1220246-2024-02618
    Event Type
    Malfunction
    Date Received
    April 30, 2024
    Date of Event
    September 24, 2021
    Report Date
    April 30, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867034860
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THE COMPLAINT IS NOT CONFIRMED. ONE UNPACKAGED AR-5025TBC-16, BATCH 031724 WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION CONCLUDED WITHOUT THE OBSERVANCE OF ANY DAMAGE OR ABNORMALITIES. NO PROBLEM FOUND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE IS NOT GOING THROUGH ANYMORE. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154901 BIO-COMPRESSION CANN DILATOR TAP, 16MM ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. BIO-COMPRESSION CANN DILATOR TAP, 16MM 031724 00888867034860

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown