TRIWAY N02 00011Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03760225717950), received between Dec 3, 2020 and Dec 3, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ANKLE SURGERY: THE TRIWAY(R) TTC ARTHRODESIS SYSTEM IS INTENDED FOR USE IN TIBIOTALOCALCANEAL ARTHRODESIS AND TREATMENT OF TRAUMA TO THE HINDFOOT AND DISTAL TIBIA. EXAMPLES INCLUDE: - POST-TRAUMATIC AND DEGENERATIVE ARTHRITIS INVOLVING BOTH ANKLE AND SUBTALAR JOINTS - RHEUMATOID ARTHRITIS WITH SEVERE DEFORMITY - REVISION OF FAILED ANKLE ARTHRODESIS WITH SUBTALAR INVOLVEMENT OR WITH INSUFFICIENT TALAR BODY - REVISION OF FAILED TOTAL ANKLE ARTHROPLASTY WITH SUBTALAR INTRUSION - TALAR DEFICIENCY CONDITIONS, INCLUDING AVASCULAR NECROSIS (REQUIRING A TIBIOCALCANEAL ARTHRODESIS) - NEUROARTHROPATHY OR NEUROMUSCULAR DEFORMITY OR OTHER NEUROMUSCULAR DISEASE WITH SEVERE DEFORMITY OR INSTABILITY OF THE ANKLE, INCLUDING CHARCOT FOOT - SEVERE PILON FRACTURES WITH TRAUMA TO THE SUBTALAR JOINT - MALUNITED TIBIAL PILON FRACTURES THE IN2BONES TRIWAY(R) TTC ARTHRODESIS NAIL HAS TO BE FIXED WITH THE ASSOCIATED: TIBIAL FIXATION USING COTTER SCREWS DIAMETER 5.0MM ; TALAR FIXATION USING COTTER SCREWS DIAMETER 5.0MM ; CALCANEUS FIXATION USING COTTER SCREWS DIAMETER 5.0MM. THE ADDITION OF AN IBS" 6.5MM COMPRESSION SCREW THROUGH THE SUBTALAR JOINT AND THROUGH THE NAIL IS REQUIRED. ALL SCREWS ARE INTENDED T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10940182 ↗
• MalfunctionDec 3, 2020Break; Difficult to Insert; Off-Label Use; Failure to Align; Difficult to Advance

  ANKLE SURGERY: THE TRIWAY TTC ARTHRODESIS SYSTEM IS INTENDED FOR USE IN TIBIOTALOCALCANEAL ARTHRODESIS AND TREATMENT OF TRAUMA TO THE HINDFOOT AND DISTAL TIBIA. EXAMPLES INCLUDE: POST-TRAUMATIC AND DEGENERATIVE ARTHRITIS INVOLVING BOTH ANKLE AND SUBTALAR JOINTS. RHEUMATOID ARTHRITIS WITH SEVERE DEFORMITY. REVISION OF FAILED ANKLE ARTHRODESIS WITH SUBTALAR INVOLVEMENT OR WITH INSUFFICIENT TALAR BODY. REVISION OF FAILED TOTAL ANKLE ARTHROPLASTY WITH SUBTALAR INTRUSION. TALAR DEFICIENCY CONDITIONS, INCLUDING AVASCULAR NECROSIS (REQUIRING A TIBIOCALCANEAL ARTHRODESIS). NEUROARTHROPATHY OR NEUROMUSCULAR DEFORMITY OR OTHER NEUROMUSCULAR DISEASE WITH SEVERE DEFORMITY OR INSTABILITY OF THE ANKLE, INCLUDING CHARCOT FOOT. SEVERE PILON FRACTURES WITH TRAUMA TO THE SUBTALAR JOINT. MALUNITED TIBIAL PILON FRACTURES THE IN2BONES TRIWAY¿ TTC ARTHRODESIS NAIL HAS TO BE FIXED WITH THE ASSOCIATED: TIBIAL FIXATION USING COTTER SCREWS DIAMETER 5.0MM ; TALAR FIXATION USING COTTER SCREWS DIAMETER 5.0MM ; CALCANEUS FIXATION USING COTTER SCREWS DIAMETER 5.0MM. THE ADDITION OF AN IBS" 6.5MM COMPRESSION SCREW THROUGH THE SUBTALAR JOINT AND THROUGH THE NAIL IS REQUIRED. ALL SCREWS ARE INTENDED TO BE IMPLATED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10940169 ↗