BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNEE SCORPION

    MDR report key: 19165641 · Received April 23, 2024

    Report

    Report Number
    1220246-2024-02263
    Event Type
    Malfunction
    Date Received
    April 23, 2024
    Date of Event
    March 1, 2021
    Report Date
    April 23, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    NBH
    UDI-DI
    00888867196322
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    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 RELATED CONDITION IS TYPICALLY CAUSED BY APPLYING EXCESSIVE FORCE WHILE GRASPING AND MANIPULATING SUTURE AND TISSUE OR APPLYING EXCESSIVE LEVERAGING FORCES. BROKEN TIP WAS NOT RETURNED ALONG WITH THE COMPLAINT DEVICE. FUNCTION TEST COULD NOT BE PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A MENISCAL ROOT PROCEDURE, THE SURGEON HAD A FEW MISFIRES WITH THE NEEDLE. WHEN THE SURGEON TRIED LOADING THE SUTURE AGAIN, THE SCRUB TECH NOTICED THAT THE BOTTOM JAW WAS EXTREMELY WOBBLY. THE SURGEON TOUCHED IT AND THE BOTTOM JAW BROKE OFF. THE CASE WAS COMPLETED BY USING A NEW AR-12990 WITHOUT FURTHER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272987 KNEE SCORPION MANUAL INSTR, GENERAL SURGICAL NBH ARTHREX, INC. KNEE SCORPION 69212 00888867196322

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown