BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASTPASS SCORPION

    MDR report key: 19211774 · Received April 30, 2024

    Report

    Report Number
    1220246-2024-02584
    Event Type
    Malfunction
    Date Received
    April 30, 2024
    Date of Event
    March 1, 2021
    Report Date
    April 30, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867015982
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DR
    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 PRECISE CAUSE FOR A BROKEN NIPPLE ON THE FINGER COULD NOT BE DETERMINED. THE MATING PART (NEEDLE) WAS NOT RETURNED ALONG WITH COMPLAINT DEVICE. FUNCTION TEST COULD NOT BE PERFORMED DUE TO THE RELATED CONDITION. UNRELATED, LASER MARKINGS ON THE HANDLE BECAME RUSTED AND DISCOLORED. THE CONDITION OF THE DEVICE WAS CONSISTENT WITH QUESTIONABLE USER HANDLING AND EXPECTED WEAR WITH USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPIC PROCEDURE, THE AR-13997SF, WOULD NOT GRASP CORRECTLY. THE CASE WAS COMPLETED BY USING ANOTHER AR-13997SF WITHOUT FURTHER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176066 FASTPASS SCORPION ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. FASTPASS SCORPION 53349 00888867015982

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown