FITBONE TAA SYSTEM 1 (REF 60001422)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 18053340343992), received between Jan 29, 2026 and Feb 20, 2026 — classified as 1 injury, 1 malfunction.

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 16, 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.

• InjuryFeb 20, 2026Break

  RECEIVED INFORMATION STATING THAT A FITBONE NAIL BROKE DURING TREATMENT. ON (B)(6) 2026, PATIENT UNDERWENT A REVISION PROCEDURE TO REMOVE THE NAIL. FURTHER INFORMATION RECEIVED ON (B)(6) 2026: BATCH NUMBER OF THE FITBONE NAIL WHICH BROKE: B5157349, DATE OF INITIAL SURGERY: (B)(6) 2025 DATE OF AWARENESS OF THE PROBLEM: 19/05/2025, WEIGHT OF THE PATIENT: AROUND 75 KG. THE NAIL AND THE BROKEN PORTION WERE COMPLETELY REMOVED FROM THE PATIENT DURING THE SURGICAL REVISION DONE ON (B)(6).

  Patient problems: Loss of fracture reduction

  MAUDE report 24399562 ↗
• MalfunctionJan 29, 2026Mechanical Problem

  AS PER REPORTER, DURING THE SURGICAL PROCEDURE FOR A FITBONE NAIL IMPLANTATION, THE NAIL DID NOT FUNCTION. ANOTHER NAIL WITH THE SAME DIAMETER AND LENGTH WAS IMPLANTED CAUSING A SURGICAL DELAY OF 45 MINUTES. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24207074 ↗