FITBONE TAA SYSTEM 1 (REF 60001468)Recalls & reported problems
Orthofix Srl · FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA1160-F-225 · Class 2 · Implant
All models of FITBONE TAA SYSTEM (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 18053340344067), received between Jun 20, 2025 and Sep 24, 2026 — classified as 5 injuries.
The most frequently reported specific device problem is “Mechanical Jam” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Mechanical Jam2
- Mechanical Problem2
- Break1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Failure of Implant1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjurySep 24, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50879073 ↗InjuryApr 29, 2026Break
AS PER REPORTER, DURING TREATMENT FOR FEMUR FRACTURE THE FITBONE NAIL BROKE. AS PER REPORTER THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026, WHERE THE BROKEN NAIL WAS REPLACED WITH ANOTHER NAIL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25027806 ↗InjuryNov 26, 2025Mechanical Problem; Mechanical Problem
AS PER REPORTER, DURING TREATMENT FOR FEMUR LENGTHENING, THE FITBONE NAIL STOPPED LENGTHENING. AS PER REPORTER THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23654799 ↗InjuryNov 13, 2025Mechanical Problem; Mechanical Jam; Mechanical Problem; Mechanical Jam
AS PER REPORTER, DURING TREATMENT FOR FEMUR LENGTHENING, THE FITBONE NAIL STOPPED LENGTHENING. AS PER REPORTER THE PATIENT WILL UNDERGO A REVISION PROCEDURE. FURTHER INFORMATION RECEIVED: AS PER THE REPORTER DURING A REVISION SURGERY ON (B)(6) 2025, THE NAIL WAS REPLACED WITH ANOTHER NAIL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23540202 ↗InjuryJun 20, 2025Fracture; Fracture
RECEIVED INFORMATION STATING THAT A FITBONE NAIL BROKE DURING TREATMENT. PATIENT UNDERWENT A REVISION PROCEDURE THAT EXTENDED THE SURGICAL PROCEDURE.
Patient problems: Failure of Implant
MAUDE report 22295867 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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