BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIWAY® TTC ARTHRODESIS SYSTEM

    MDR report key: 23106993 · Received September 22, 2025

    Report

    Report Number
    3010470577-2024-07352
    Event Type
    Injury
    Date Received
    September 22, 2025
    Date of Event
    May 17, 2024
    Report Date
    September 22, 2025
    Manufacturer
    IN2BONES SAS
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH RECORDS #2202186, 2203034, 2209278, 2306195 AND 2307031 WERE REVIEWED AND ASSESSED. THERE IS NO NC THAT MIGHT EXPLAIN THE COMPLAINT, AND NO DEROGATION MENTIONED. AS PER RECEIVED INFORMATION, PATIENT HAS CHARCOT DISEASE: THIS NEUROLOGICAL DEGENERATIVE DISEASE DAMAGES THE PATIENT NERVES (USUALLY STARTING WITH THE LOWER LIMBS) AND CAN LED TO NON-DETECTION OF INJURIES OR INFECTIONS IN THE FOOT, DUE TO THE LACK OF PAIN SENSATION IN THE AREA WHERE THE NERVES ARE DAMAGED. THE EVENT "CALCANEAL SCREW COMES BACK OUT" IS CONSECUTIVE TO THE EVENT OF "MIGRATION OF THE IMPLANT POSITION", WHICH IS AN EXPECTED SIDE EFFECT ALREADY DOCUMENTED IN THE RANGE TECHNICAL FILE, THAT IS ALSO IN-LINE WITH THE CURRENT STATE OF THE ART FOR TIBIOTALOCALCANEAL ARTHRODESIS, AS DOCUMENTED IN TRIWAY IFU (IFU024 REV04, SECTION 5. COMPLICATIONS: "MIGRATION OF THE IMPLANT POSITION") AND TRIWAY CER (TRIWAY CER REV06, TABLE 03).

    Description of Event or Problem · 0

    THE TRIWAY® TIBIOTALOCALCANEAL (TTC) ARTHRODESIS SYSTEM IS A UNIQUE NAIL SYSTEM FOR ANKLE ARTHRODESIS PROVIDING A HIGH STABILITY AND RIGID FIXATION. THE SYSTEM IS COMPOSED OF AN ANGULATED NAIL AVAILABLE IN SEVERAL SIZES (DIAMETER 10, 11, 12MM, LENGTHS FROM 160MM TO 250MM) AND DIFFERENT SCREWS FOR BONY FIXATION. RIGID FIXATION IS ACHIEVED BY: - TWO 5.0MM DIAMETER COTTER SCREWS OR TWO 5.0MM DIAMETER HEADED SCREWS FOR TIBIAL FIXATION. - ONE 5.0MM DIAMETER COTTER SCREW FOR TALAR FIXATION. - ONE 5.0MM DIAMETER COTTER SCREW FOR CALCANEUS FIXATION. - ONE I.B.S® 6.5MM COMPRESSION SCREW INSERTED IN AN OBLIQUE WAY TO PROVIDE ADDITIONAL COMPRESSION THROUGHOUT THE NAIL, BETWEEN THE CALCANEUS AND THE TALUS. EVENT DESCRIPTION: COMPLAINT OPENED ON JULY 30TH, 2024 REGARDING A TRIWAY SCREW COMING OUT OF A PATIENT'S FOOT (PATIENT WITH CHARCOT DISEASE) - INFORMATION COMMUNICATED ORALLY BY THE MARKETING TEAM. ADDITIONAL INFORMATION RECEIVED BY EMAIL ON JULY 31ST, 2024: "PLEASE SEE DESCRIPTION FROM A RECENT PATIENT WHO HAS RECEIVED A TRIWAY NAIL. CLEARLY THE BACKING OUT OF THE CALC SCREW IS EXCESSIVE. ALSO, SIMILAR REPORT FROM A SECOND SURGEON, SORRY NO PICTURES, OF THE CALC SCREW." "I HAVE ALREADY TWO SURGEONS THAT THEY HAVE HAD TO REMOVE THE CALC SCREW ON THE TRIWAY BECAUSE HAVE HAD BACKED OUT. BOTH ON CHARCOT PATIENTS THOUGH. FIRST CASE WAS AT (B)(6) WITH MR (B)(6) SECOND CASE AT (B)(6) WITH MR (B)(6). NONE OF THEM BLAMING THE SET". ADDITIONAL INFORMATION RECEIVED ON AUGUST 1ST, 2024: "I'VE ALSO JUST BEEN INFORMED THAT THERE IS NOW A THIRD CASE WITH A SIMILAR SITUATION TO MANAGE AT SOME POINT IN THE NEAR FUTURE". ADDITIONAL INFORMATION RECEIVED ON 12-AUGUST-2024: EMAIL CONTAINS INFORMATION REQUESTED FOR RC PROCESSING, AS WELL AS AN ATTACHED FILE CONTAINING PICTURES AND X-RAYS FOR EACH OF THE 3 INVOLVED PATIENTS. PATIENT 2 ((B)(6) HOSPITAL): THE FIRST SURGERY TOOK PLACE ON (B)(6) 2024 AND THE INCIDENT OCCURRED 11 WEEKS AFTER THE SURGERY. CONSEQUENTLY, THE PATIENT HAD ANOTHER SURGERY ON (B)(6) 2024 TO REMOVE THE CALCANEAL SCREW. PATIENTS 1 AND 3 WILL BE FOCUSED ON OTHER MDR REPORTS. IN ADDITION, AS PER INFORMATION RECEIVED ON THE 12-AUG-2024 ABOUT THESE 3 INVOLVED PATIENTS, THERE WAS NO ACCIDENT OR FALLS BEFORE THE INCIDENTS, AND ALL PATIENTS DID FOLLOW THE RECOMMENDED POST OP INSTRUCTIONS. ADDITIONAL INFORMATION RECEIVED ON 14-NOV-2024: "THE PHOTOS WERE REVIEWED BY AN HCP: THE FIRST TWO CASES WERE CHARCOT PATIENTS.CASE THREE NO CHARCOT, WAS POST REMOVAL AND ANKLE REPLACEMENT." THIS REPORTABLE EVENT IS PART OF A REMEDITION RESULTING FROM A 483 LETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2510777 TRIWAY® TTC ARTHRODESIS SYSTEM TRIWAY HWC IN2BONES SAS 2209278; 2306195; 2307031

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention