BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASTPASS SCORPION

    MDR report key: 18228907 · Received November 29, 2023

    Report

    Report Number
    1220246-2023-08975
    Event Type
    Malfunction
    Date Received
    November 29, 2023
    Date of Event
    November 1, 2023
    Report Date
    May 28, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867015982
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H6. COMPLAINT IS NOT CONFIRMED. FUNCTIONAL TESTING WAS PERFORMED ON THE RETURNED AR-13997SF WITH A KNOWN GOOD AR-13991N AND FOUND THAT THE DEVICE WORKS AS INTENDED AND THE NEEDLE WAS ABLE TO FIRE THROUGH THE SHAFT AND WINDOW OF THE DEVICE AND WAS ABLE TO CATCH THE SUTURE. VISUAL INSPECTION NOTED NO PROBLEMS WITH THE EXTERIOR OF THE DEVICE. NO PROBLEM FOUND. REFER TO INVESTIGATION PHOTO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SURGERY THE SURGEON DID NOT SUCCEEDED TO USE THE SCORPION DEVICE CORRECTLY AND ANOTHER ONE WAS USED. THE NEXT DAY AFTER SURGERY, FEW FRAGMENTS WERE SEEN ON THE X-RAY INSIDE OF THE JOINT. NO FURTHER INFORMATION RECEIVED. ***UPDATE AVOE (B)(6) 2023 IT WAS FURTHER REPORTED THAT THE SUREFIRE¿ SCORPION¿ NEEDLE AR-13991N (LOT: 15062341) WAS USED WITH THE REPORTED SCORPION DEVICE. IT IS UNCLEAR IF THE FRAGMENTS CAME FROM THE SCORPION OR THE NEEDLE. ***UPDATE AVOE (B)(6) 2023 IT WAS CONFIRMED THAT FOR THE MOMENT NO SECOND SURGERY IS PLANNED TO REMOVE THE FRAGMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982655 FASTPASS SCORPION ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. FASTPASS SCORPION 81561 00888867015982

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown