MAUDE Adverse Event Report: IN2BONES SAS TRIWAY® TTC ARTHRODESIS SYSTEM

Catalog Number	N20 ST101 + N20 ST112
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
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: 2 patients treated with triway nails required hardware removal due to infections.During removal of the second nail, the extractor could not be mounted on the nail.Patient 1: born (b)(6) 1954.Nail inserted (b)(6) 2021.Nail removed (b)(6) 2022.Patient 2: born (b)(6) 1964.Nail inserted (b)(6) 2021.Nail removed (b)(6) 2022.The company was not informed until the second patient's nail was removed.Biopsy samples were taken during the procedure.This event is reported according to the remediation plan following fda observation 1 from (b)(6) 2025.
Additional Manufacturer Narrative
Batch history records of the products involved in this complaint were reviewed and no non-conformity which might explain the complaint was determined.Report received from the healthcare facility on (b)(6) 2022 stating that the extractor malfunctioned and that there was no damage nor any physical injury made to the patient.Elements of the investigation stated above lead to believe that the extractor's malfunction was caused by the fact that the thread inside the nail explanted was damaged.Several attempts were made to inquire with the healthcare facility if the explanted nail could be retrieved for further testing; the healthcare facility answered on the (b)(6) 2022 that the implant was not saved and therefore cannot be inspected.No cause about the infection on the 2 patients was determined due to the lack of information.Infections are an expected adverse event as documented in the triway ifu, and technical documentation.

• Brand Name: TRIWAY® TTC ARTHRODESIS SYSTEM
• Common Device Name: TRIWAY
• Manufacturer (Section D): IN2BONES SAS; 28 chemin du petit bois; bâtiment 2; ecully, 60130 ; FR 60130
• Manufacturer (Section G): IN2BONES SAS; 28 chemin du petit bois; bâtiment 2; ecully 69130 ; FR 69130
• Manufacturer Contact: martin geertsema ; 28 chemin du petit bois; bâtiment 2; ecully 69130 ; FR 69130
• MDR Report Key: 23081844
• Report Number: 3010470577-2025-05311
• Device Sequence Number: 4786297
• Product Code: HSB
• UDI-Device Identifier: 03760225717493
• UDI-Public: 3760225717493
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: N20 ST101 + N20 ST112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male