BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCORPION-MULTIFIRE

    MDR report key: 19547081 · Received June 17, 2024

    Report

    Report Number
    1220246-2024-05864
    Event Type
    Malfunction
    Date Received
    June 17, 2024
    Date of Event
    February 18, 2021
    Report Date
    June 17, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867015968
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. THE MATING PART (NEEDLE) WAS NOT RETURNED ALONG WITH THE COMPLAINT DEVICE. FUNCTION TEST COULD NOT BE PERFORMED DUE TO THE RELATED CONDITION. BASED OFF THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE/MISHANDLING DUE TO DAMAGE TO THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT DURING AN ACL PROCEDURE THE TOP JAW ON THE AR-13996, SCORPION CAME LOOSE. THE CASE WAS COMPLETED USING AR-13997MF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1332823 SCORPION-MULTIFIRE ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. SCORPION-MULTIFIRE 11790939 00888867015968

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown