MAUDE Adverse Event Report: IN2BONES SAS TRIWAY; FIXATION SCREW TRIWAY ARTHRODESIS NAIL

Model Number	N02 00004
Medical Device Problem Codes	Mechanical Problem (1384); Use of Device Problem (1670)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the assembly of the jig for the triway nail, the connector equipped with the fixation screw became stuck in the compression wheel and the positioning guide.Due to the flat side of the screw, it tends to sit at an angle in the threading, causing it to jam.The screw then becomes very difficult to loosen or remove.The customer eventually managed, after several attempts, to free the screw and continue the procedure.

• Brand Name: TRIWAY
• Common Device Name: FIXATION SCREW TRIWAY ARTHRODESIS NAIL
• Manufacturer (Section D): IN2BONES SAS; immeuble sequoia 3; 97 allée alexandre borodine; saint-priest, 69800 ; FR 69800
• Manufacturer (Section G): IN2BONES SAS; immeuble sequoia 3; 97 allée alexandre borodine; saint-priest, 69800 ; FR 69800
• Manufacturer Contact: benjamin krempel ; immeuble sequoia 3; 97 allée alexandre borodine; saint-priest, 69800 ; FR 69800
• MDR Report Key: 24711933
• Report Number: 3010470577-2026-03011
• Device Sequence Number: 5989205
• Product Code: FZX
• UDI-Device Identifier: 03760225717882
• UDI-Public: 03760225717882
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: N02 00004
• Device Catalogue Number: N02 00004
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Female