BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T25 HEXALOBE, ISO, CANN.

    MDR report key: 17246476 · Received July 3, 2023

    Report

    Report Number
    1220246-2023-07014
    Event Type
    Malfunction
    Date Received
    July 3, 2023
    Date of Event
    June 7, 2023
    Report Date
    September 28, 2023
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867263789
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT IS CONFIRMED. VISUAL EVALUATION NOTED THAT THE DRIVE GEOMETRY AT THE DISTAL TIP OF THE RETURNED AR-8770-01 HAD BROKEN. NO FRAGMENTS WERE RETURNED FOR INSPECTION. THE MOST LIKELY CAUSE IS ATTRIBUTED TO OVER-TORQUING/OVER-ENGAGING THE DRIVER WITHIN THE SCREW HEAD. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE.

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT HAS NOT YET BEEN DETERMINED AS THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED, INCLUDING A MOST LIKELY CAUSE IF A ROOT CAUSE CAN NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A FOOT SURGERY THE DEVICE BROKE OFF WHEN SCREWING A SCREW INTO THE CALCANEUS. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE AVOE (B)(6) 2023 IT WAS CONFIRMED THAT NO PART OF THE DEVICE BROKE OFF. THE DEVICE CRACKED AND NO PART OF THE DEVICE HAD TO BE REMOVED FROM THE PATIENT. UPDATE AVOE (B)(6) 2023 FURTHER INFORMATION WAS PROVIDED THAT A PART OF THE DEVICE BROKE OFF, SINCE HALF OF THE TORX ATTACHMENT IS MISSING FROM THE DEVICE. NO FRAGMENTS REMAINED INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26494 T25 HEXALOBE, ISO, CANN. ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. T25 HEXALOBE, ISO, CANN. 1392130 00888867263789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown