BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIWAY® TTC ARTHRODESIS SYSTEM

    MDR report key: 23107067 · Received September 22, 2025

    Report

    Report Number
    3010470577-2024-07353
    Event Type
    Injury
    Date Received
    September 22, 2025
    Date of Event
    November 3, 2023
    Report Date
    September 22, 2025
    Manufacturer
    IN2BONES SAS
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH RECORDS #2112040, 2301160, 2303344, 2303349 AND 2306195 WERE REVIEWED AND ASSESSED. THERE IS NO NC THAT MIGHT EXPLAIN THE COMPLAINT, AND NO DEROGATION MENTIONED. SIX X-RAYS WERE RECEIVED. TWO X-RAYS PERFORMED THE (B)(6) 2025 (SURGERY DATE) AND ONE DONE AT 5 WEEKS POST-OP ARE SHOWING THE CALCANEAL SCREW DID NOT MOVE. THE LAST X-RAY PERFORMED AT 6- AND 9-MONTHS POST-OP ARE SHOWING THAT THE CALCANEAL SCREW MIGRATED OUT OF THE BONE, THIS LAST X-RAY AT 9 MONTHS POST-OP SHOWING THAT THE SCREW STARTS TO COME OUT OF FOOT SKIN. 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 (B)(6) 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. 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 (B)(6) 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 3 ((B)(6) HOSPITAL): THE FIRST SURGERY TOOK PLACE ON (B)(6) 2023, AND THE INCIDENT (I.E. PROXIMAL TIBIAL SCREW BACK OUT) OCCURRED 12 WEEKS AFTER THE SURGERY. CONSEQUENTLY, THE PATIENT HAD ANOTHER SURGERY ON (B)(6) 2023 TO REMOVE THE CALCANEAL SCREW. PATIENTS 1 AND 2 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 A 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
    2180688 TRIWAY® TTC ARTHRODESIS SYSTEM TRIWAY HWC IN2BONES SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention