TRIWAY N02 00005Recalls & reported problems
In2bones · INDEX TAB TRIWAY ARTHRODESIS NAIL · Class 1
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 03760225717899), received between Feb 28, 2025 and Feb 28, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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
- Difficult or Delayed Positioning1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 28, 2025Difficult or Delayed Positioning; Difficult or Delayed Positioning
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. EVENT DESCRIPTION: SURGEON REPORTED THAT: "OPENING OF THE COMPLAINT TODAY BECAUSE I HAVE JUST LEARNED OF THE PATIENT'S RECOVERY ON (B)(6). DURING SURGERY ON (B)(6): CONTROL OF THE SIGHTS BEFORE IMPLANTATION OK. DIFFICULTIES WITH THE IBS 6.5 TRANSFOCAL SCREW WHOSE DRILL BIT COMES UP AGAINST THE NAIL. DISMANTLING RECHECKS TARGETS = THE DRILL BIT SEEMS SLIGHTLY DEVIATED BUT PASSES THROUGH THE IBS SCREW HOLE. SECOND EDIT/SAME RESULT. PLACEMENT OF THE SCREW AFTER SEVERAL MANIPULATIONS. AT THE OP CHECKPOINT, THE CALCA SCREW IS NOT THE HIGHLIGHT. IT APPEARS THAT THE TRIWAY GUIDE IS DEFECTIVE. MAIL MADE TO LOGISTICS TO ISOLATE THE GUIDE UPON HIS RETURN TO ECULLY. A SECOND ANCILLARY WORKER LEAVES TODAY FOR THE RECOVERY OF THE (B)(6)." ADDITIONAL INFORMATION WAS PROVIDED: IT IS REPORTED THAT: TYPE OF PROCEDURE IS ANKLE ARTRODESIS. PATIENT/USER OUTCOME FROM ADVERSE EVENT IS PROLONGED H
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21492069 ↗
Other Guide, Surgical, Instrument devices
- NA 03.037.017Synthes GmbH · Guide, surgical, instrument346 reports
- EVOS 71174934Smith & Nephew, Inc. · Guide, surgical, instrument149 reports
- LCP 323.042Synthes GmbH · Guide, surgical, instrument129 reports
- DJO SURGICAL 342-10-705Encore Medical, L.P. · Guide, Surgical, Instrument1 recall51 reports
- DJO SURGICAL 341-10-707Encore Medical, L.P. · Guide, Surgical, Instrument81 reports
- NA 03.010.404Synthes GmbH · Guide, surgical, instrument73 reports
- DJO SURGICAL 341-14-708Encore Medical, L.P. · Guide, Surgical, Instrument1 recall22 reports
- DJO SURGICAL 341-10-711Encore Medical, L.P. · Guide, Surgical, Instrument1 recall16 reports
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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