FITBONE TAA SYSTEM 1 (REF 60001445)Recalls & reported problems
Orthofix Srl · FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA1160-T-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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 18053340344012), received between Jun 26, 2026 and Sep 11, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Mechanical Jam” (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.
Reports received per month
Most reported problems
Device problems
- Mechanical Jam1
- Patient Device Interaction Problem1
Patient problems
- Failure of Implant1
- Medical device site infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 11, 2026Mechanical Jam
Received information that alleged the Fitbone nail stop working during treatment, patient underwent a revision procedure.
Patient problems: Failure of Implant
MAUDE report 50728910 ↗InjuryJun 26, 2026Patient Device Interaction Problem
AS PER THE REPORTER THE CABLE OF THE FITBONE NAIL HAS PERFORATED THE INFRAPATELLAR SCAR 6 WEEKS POST SURGERY. THE WOUND IS INFECTED. PATIENT NEEDS ANTIBIOTIC TREATMENT AND POSSIBLY RE-SURGERY.
Patient problems: Medical device site infection
MAUDE report 25635278 ↗
Other Rod, Fixation, Intramedullary And Accessories devices
- NA 03.033.001Synthes GmbH · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES265 reports
- GAMMA 3125-1180SStryker GmbH · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES249 reports
- NA 03.037.026Synthes GmbH · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES225 reports
- PRECICE® Intramedullary Limb Lengthening System LSC5-075Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls2 reports
- PRECICE® Intramedullary Limb Lengthening System LSC5-045Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls1 report
- TRIGEN 71674067Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES201 reports
- PRECICE® Intramedullary Limb Lengthening System LSC5-050Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls1 report
- PRECICE Intramedullary Limb Lengthening System LSB5-075Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls0 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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