BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANT SYSTEM, CPR MINI SCORPION DX

    MDR report key: 19570610 · Received June 19, 2024

    Report

    Report Number
    1220246-2024-06218
    Event Type
    Malfunction
    Date Received
    June 19, 2024
    Date of Event
    April 14, 2023
    Report Date
    June 19, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    GAT
    UDI-DI
    00888867044692
    PMA / PMN Number
    K122374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    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 IS NOT CONFIRMED. UPON VISUAL EVALUATION, THE GREEN PIGTAIL HAD NO ISSUES. NO PROBLEM FOUND. FUNCTIONAL TESTING NOTED THE SUTURE LASSO WENT THROUGH THE GREEN PIGTAIL.

    Description of Event or Problem · 0

    ON 4/17/2032, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA PHONE THAT AN AR-8690DS LEFT GREEN PIGTAIL WOULD NOT ALLOW THE SUTURE TO PASS THROUGH. THE SURGEON WAS ABLE TO USE THE RED RIGHT PIG TAIL. THIS WAS DISCOVERED DURING A PROCEDURE A WEIL OSTEOTOMY ON 4/14/2023. THE CASE WAS DELAYED TEN TO TWELVE MINUTES; HOWEVER, THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702548 IMPLANT SYSTEM, CPR MINI SCORPION DX POLYETHYLENE SYNTHETIC SUTURE GAT ARTHREX, INC. IMPLANT SYSTEM, CPR MINI SCORPION DX 14960089 00888867044692

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown