TRIWAY N20 ST101Recalls & reported problems
In2bones · TRIWAY ARTHRODESIS NAIL DIAM 10 MM LG 160 RIGHT STERILE · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03760225717493), received between Sep 18, 2025 and Sep 18, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
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 A
Patient problems: Unspecified Infection
MAUDE report 23081844 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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