BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERMX NITI STAPLE W/ INSTRS, 20W X 20L

    MDR report key: 19369800 · Received May 22, 2024

    Report

    Report Number
    1220246-2024-03634
    Event Type
    Injury
    Date Received
    May 22, 2024
    Date of Event
    July 5, 2022
    Report Date
    May 22, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    JDR
    UDI-DI
    00888867300965
    PMA / PMN Number
    K203180
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED OFF THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER-APPLIED EXCESSIVE MECHANICAL FORCES. IT WAS COMMUNICATED THAT THE PATIENT HAS NO ISSUES, AND THE JOINT HAS SUCCESSFULLY FUSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER THE DEVICE WAS IMPLANTED INTO A PATIENT IT WAS FOUND THAT ONE LEG OF THE STAPLE HAS BROKEN HALF WAY DOWN. THE PATIENT HAS NO ISSUES AND THE JOUNT HAS SUCCESSFULLY FUSED. NO FURTHER INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1609659 SUPERMX NITI STAPLE W/ INSTRS, 20W X 20L STAPLE, FIXATION, BONE JDR ARTHREX, INC. SUPERMX COMPRESSION STAPLE, 20W X 20L UNK 00888867300965

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other