BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERCLAGE TENSIONER RATCHETING HANDLE

    MDR report key: 19155056 · Received April 22, 2024

    Report

    Report Number
    1220246-2024-02223
    Event Type
    Malfunction
    Date Received
    April 22, 2024
    Date of Event
    March 10, 2021
    Report Date
    June 24, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00858325005176
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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 COULD NOT BE CONFIRMED. ONE UNPACKAGED AR-7801, BATCH 104731 CERCLAGE TENSIONER RATCHETING HANDLE WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION IDENTIFIED SIGNS OF WEAR AND TEAR ACROSS THE DEVICE, SUCH AS DISCOLORATION ACROSS THE METALLIC COMPONENTS. THE OBSERVED CONDITION OF THE TENSIONER RATCHETING HANDLE IS CONSISTENT WITH THE MANUFACTURE DATE OF 2017. THE DEVICE WAS FUNCTIONALLY TESTED WITH THE RETURNED AR-7800, BATCH 051650 THAT WAS RETURNED ON (B)(4). NO PROBLEM WAS NOTED. AS THE FIBERTAPE DETAILED IN THE EVENT DESCRIPTION WAS NOT RETURNED, THE REPORTED FAILURE MODE CANNOT BE VERIFIED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G4, H3. H6. THE COMPLAINT COULD NOT BE CONFIRMED. ONE UNPACKAGED AR-7801, BATCH 104731 CERCLAGE TENSIONER RATCHETING HANDLE WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION IDENTIFIED SIGNS OF WEAR AND TEAR ACROSS THE DEVICE, SUCH AS DISCOLORATION ACROSS THE METALLIC COMPONENTS. THE OBSERVED CONDITION OF THE TENSIONER RATCHETING HANDLE IS CONSISTENT WITH THE MANUFACTURE DATE OF 2017. THE DEVICE WAS FUNCTIONALLY TESTED WITH THE RETURNED AR-7800, BATCH 051650 THAT WAS RETURNED ON (B)(4). NO PROBLEM WAS NOTED. AS THE FIBER TAPE DETAILED IN THE EVENT DESCRIPTION WAS NOT RETURNED, THE REPORTED FAILURE MODE CANNOT BE VERIFIED. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO WEAR AND TEAR. D9 - DATE OF RECEIPT

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DISTAL FEMUR FRACTURE SURGERY THREE FIBERTAPES (AR-7267, LOT S705864) BROKE INSIDE THE PATIENT WHILE USING THE CERCLAGE TENSIONER (AR-7800, LOT 051650). ONE BROKE DURING INITIAL TENSIONING AND THE SECOND AND THIRD BROKE WHEN THE FINAL TENSIONING ON TOP OF THE HALF HITCH WAS DONE. ALL THREE DEVICES BROKE IN THE KNOT. THE BROKEN DEVICE CERCLAGE WAS REMOVED FROM THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. THE SURGEON SWITCHED TO A CERCLAGE WIRE IN METAL. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272749 CERCLAGE TENSIONER RATCHETING HANDLE ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. CERCLAGE TENSIONER RATCHETING HANDLE 104731 00858325005176

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown