BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERCLAGE TENSIONER RATCHETING HANDLE

    MDR report key: 17975432 · Received October 20, 2023

    Report

    Report Number
    1220246-2023-08274
    Event Type
    Malfunction
    Date Received
    October 20, 2023
    Date of Event
    September 21, 2023
    Report Date
    November 13, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00858325005176
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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, H3, H6. THE COMPLAINT IS NOT CONFIRMED. ONE UNPACKAGED AR-7801 SERIAL/BATCH NUMBER (B)(6) WAS RECEIVED FOR INVESTIGATION. FUNCTIONAL TESTING WITH THE RETURNED MATING PART AR-7800 BATCH 052144 AND A SUTURE FOUND NO ISSUES WHEN THE SUTURE WAS RATCHETING; NO CUT PIECES OF THE SUTURE WERE OBSERVED AFTER INSPECTING. HOWEVER, IT WAS FOUND RESISTANT WHEN THE HANDLE RATCHET WAS ATTEMPTED TO SET ON THE GEAR. VISUAL EVALUATION OBSERVED SIGNS OF WEAR AND TEAR.

    Description of Event or Problem · 0

    ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-7800 FIBERTAPE CERCLAGE TENSIONER AND AN AR-7801 CERCLAGE TENSIONER RATCHETING HANDLE HAD AN ISSUE, THE TENSIONER WAS CUTTING THE TAPE WHEN TENSIONING. THIS OCCURRED DURING USE IN AN UNSPECIFIED PROCEDURE ON (B)(6) 2023 WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON (B)(6) 2023, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION VIA PHONE: THIS OCCURRED DURING A STERNAL CLOSURE PROCEDURE. WHEN THE TENSIONER WAS CUTTING THE TAPE, ALL FRAGMENTS OF THE TAPE WERE REMOVED FROM THE PATIENT. A DISPOSABLE TENSIONER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO ADVERSE EFFECT TO THE PATIENT REPORTED AND NO CASE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1996319 CERCLAGE TENSIONER RATCHETING HANDLE ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. CERCLAGE TENSIONER RATCHETING HANDLE 146173 00858325005176

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown