BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUTURELASSO, 45 DEGREE, CURVE LEFT

    MDR report key: 19514952 · Received June 11, 2024

    Report

    Report Number
    1220246-2024-05583
    Event Type
    Malfunction
    Date Received
    June 11, 2024
    Date of Event
    April 27, 2021
    Report Date
    June 11, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867031470
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED OFF THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO APPLYING EXCESSIVE MECHANICAL FORCES UPON INSERTION.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING INSERTION THE LASSO BROKE. IT WAS REPLACED AND THE SECOND ONE BROKE AS WELL. ALL WAS RETRIEVED. IT WAS REPLACED WITH A THIRD AR-4068-45L AND THE CASE WAS COMPLETED WITH NO FURTHER ISSUES. THE PATIENT IS FINE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201497 SUTURELASSO, 45 DEGREE, CURVE LEFT ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. SUTURELASSO, 45 DEGREE, CURVE LEFT 0006100103 00888867031470

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown