MalfunctionFZX
TRIWAY
Received Mar 30, 2026 · Event occurred Dec 17, 2025
Report 3010470577-2026-03011 · MDR key 24711933
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Product code (FZX)
Manufacturer (In2bones Sas)
Model (N02 00004)
Device
Generic name
Fixation Screw Triway Arthrodesis Nail
Manufacturer
In2bones SasModel number
N02 00004Catalog number
N02 00004
Product problems
- Mechanical Problem
- Use of Device Problem
Patient
81 YR · Female
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
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.