BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BANANA SUTURELASSO

    MDR report key: 19351560 · Received May 20, 2024

    Report

    Report Number
    1220246-2024-03510
    Event Type
    Malfunction
    Date Received
    May 20, 2024
    Date of Event
    April 18, 2022
    Report Date
    May 20, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867031371
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 COMPLAINT IS CONFIRMED. (1) UNPACKAGED AR-4065B WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION REVEALED THAT COMPONENT AR-4065-015, THE NITINOL WIRE LOOP, WAS BROKEN BEFORE THE WELDED END, RESULTING IN AN OPEN LOOP. NO OBSTRUCTION WAS FOUND IN THE DEVICE'S LUMEN, AND THE WIRE WAS CAPABLE OF PASSING THROUGH WITHOUT RESISTANCE. WITHOUT ADDITIONAL INFORMATION ABOUT THE DEVICE'S USAGE, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO PRYING/LEVERAGING THE SCREW DURING INSERTION AND/OR IMPROPER BONE PREPARATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SURGERY THE WIRE COULD NOT BE MOVED THROUGH. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE FROM ANOTHER MANUFACTURER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 11-MAY-2022 DW THE REPORTED DEVICE WAS RETURNED WITH A NOTE FROM THE CUSTOMER THAT THE WIRE WAS TORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856866 BANANA SUTURELASSO ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. BANANA SUTURELASSO 1111111785 00888867031371

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown