FITBONE TAA SYSTEMRecalls & reported problems across all models
Orthofix Srl · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 32
- Deaths reported
- 0
- Injuries reported
- 30
- Recalls
- 0
We found 10 models of FITBONE TAA SYSTEM by Orthofix Srl in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between Nov 28, 2024 and Sep 24, 2026 — classified as 30 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (13 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported FITBONE TAA SYSTEM problems
Device problems
- Mechanical Problem13
- Mechanical Jam8
- Break6
- Electrical /Electronic Property Problem4
- Adverse Event Without Identified Device or Use Problem3
- Fracture1
- Material Integrity Problem1
- Patient Device Interaction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- Failure of Implant5
- Loss of fracture reduction3
- Insufficient Information2
- Foreign Body In Patient1
- Implant Pain1
- Medical device site infection1
FITBONE TAA SYSTEM models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- FITBONE TAA SYSTEM 1Rod, Fixation, Intramedullary And Accessories6 reports
- FITBONE TAA SYSTEM 1Rod, Fixation, Intramedullary And Accessories6 reports
- FITBONE TAA SYSTEM 1Rod, Fixation, Intramedullary And Accessories5 reports
- FITBONE TAA SYSTEM 1Rod, Fixation, Intramedullary And Accessories5 reports
- FITBONE TAA SYSTEM 1Rod, Fixation, Intramedullary And Accessories2 reports
- FITBONE TAA SYSTEM 1Rod, Fixation, Intramedullary And Accessories2 reports
- FITBONE TAA SYSTEM 1Rod, Fixation, Intramedullary And Accessories2 reports
- FITBONE TAA SYSTEM 1Rod, Fixation, Intramedullary And Accessories2 reports
- FITBONE TAA SYSTEM 1Rod, Fixation, Intramedullary And Accessories1 report
- FITBONE TAA SYSTEM 1Rod, Fixation, Intramedullary And Accessories1 report
Recent FITBONE TAA SYSTEM adverse event reports
The 15 most recent reports across all models, 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 ↗InjurySep 15, 2026Mechanical Problem
Received information that alleged the Fitbone nail implanted on femur on (b)(6) 2026, stopped lengthening during treatment.Patient underwent a revision procedure on (b)(6) 2026 to replace the nail.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50767217 ↗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 ↗InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem
Received information of an issue during implantation of a Fitbone nail. As per reporter, during distal screw locking, the maximum available Orthofix 4.0 mm locking screw was insufficient to achieve both secure fixation and maintain transport mechanism functionality. The surgeon implanted a third-party 4.0mm Ø Steinman-Pin (steel). Allegedly, this led to a surgery delay of 60-90 minutes.The patient is stable and in good health. The receiver and control unit have been tested positive after implantation.No allegation of product malfunction was reported by the user.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50515262 ↗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 ↗InjuryJun 9, 2026Electrical /Electronic Property Problem
RECEIVED INFORMATION THAT ALLEGED THE FITBONE RECEIVER, IMPLANTED ON (B)(6) 2026, DID NOT LENGTHEN. THE RECEIVER WAS IMPLANTED AND TESTED. AS PER THE REPORTER ONE WEEK POSTOPERATIVELY LENGTHENING WAS NOT WORKING. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026 TO REPLACE THE RECEIVER. NAIL IS LENGTHENING AS INTENDED AFTER RECEIVER REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25449602 ↗InjuryMay 25, 2026Mechanical Jam
RECEIVED INFORMATION THAT ALLEGED THE FITBONE NAIL IMPLANTED ON LEFT LEG ON (B)(6) 2026, DID NOT LENGTHEN. THE NAIL WAS IMPLANTED AND TESTED. AS PER THE REPORTER AFTER REACHING THE 4.3 CM LENGTHENING, THE NAIL STOPPED WORKING. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026 TO REPLACE THE NAIL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25270445 ↗InjuryMay 12, 2026Electrical /Electronic Property Problem
RECEIVED INFORMATION THAT ALLEGED THE FITBONE RECEIVER, IMPLANTED ON (B)(6) 2026, DID NOT LENGTHEN. THE RECEIVER WAS IMPLANTED AND TESTED. AS PER THE REPORTER ONE WEEK POSTOPERATIVELY LENGTHENING WAS NOT WORKING. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026 TO REPLACE THE RECEIVER. NAIL IS LENGTHENING AS INTENDED AFTER RECEIVER REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25149734 ↗InjuryMay 12, 2026Electrical /Electronic Property Problem
RECEIVED INFORMATION THAT ALLEGED THE FITBONE RECEIVER, IMPLANTED ON (B)(6) 2026, DID NOT LENGTHEN. THE RECEIVER WAS IMPLANTED AND TESTED. AS PER THE REPORTER ONE WEEK POSTOPERATIVELY LENGTHENING WAS NOT WORKING. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026 TO REPLACE THE RECEIVER. NAIL IS LENGTHENING AS INTENDED AFTER RECEIVER REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25147093 ↗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 ↗InjuryApr 9, 2026Electrical /Electronic Property Problem; Mechanical Problem
AS PER REPORTER, DURING TREATMENT FOR RIGHT FEMUR LENGTHENING, THE FITBONE NAIL STOPPED LENGTHENING. AS PER REPORTER THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026 TO ADD AN EXTERNAL FIXATOR AND CONTINUE WITH LENGTHENING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24825651 ↗InjuryMar 26, 2026
INTERNAL BONE TRANSPORT NAIL MOTOR FAILED HALFWAY THROUGH BONE TRANSPORT REQUIRING ADDITIONAL SURGERY, ADDITIONAL ANESTHESIA AND INCREASED RISK FOR INFECTION. REQUIRED TO REMOVE INTRAMEDULLARY NAIL AND PLACE NEW INTRAMEDULLARY NAIL. MULTIPLE CONSECUTIVE XRAYS CONFIRMED FAILURE OF BONE TRANSPORT NAIL MOVEMENT.
Patient problems: Failure of Implant
MAUDE report 24702055 ↗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 ↗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 ↗
Other Orthofix Srl products
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM140 models · 5 reports · 20 recalls
- ORTHOFIX MODULSYSTEM15 models · 13 reports · 4 recalls
- Orthofix TrueLok Hexapod System (TL-HEX) V2.015 models · 45 reports · 1 recall
- ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT2 models · 2 reports · 1 recall
- Galaxy Unyco4 models · 0 reports · 1 recall
- CHIMAERA Hip Fracture System16 models · 30 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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