MAUDE Adverse Event Report: ORTHOFIX SRL FITBONE TRANSPORT NAIL TN 1180-F-A-390 STERILE

Model Number	FITBONE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Unspecified Musculoskeletal problem (4535); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device involved in this event has not been returned for investigation, but it has been requested to return.If the device is returned an investigation will be completed and a follow-up report will be submitted.Precautions from the relevant instructions for use: during the distraction and consolidation phase, weight-bearing on the operated leg should be partial and limited to 20 kg (contact with the sole of the foot).Any exceeding load may cause the fitbone intramedullary nail to break.
Event or Problem Description
Received information that alleged the fitbone nail broke during treatment, patient underwent a revision procedure.As per reporter, the physician does not believe the product malfunctioned, the patient experienced a fall and weightbearing may have contributed to event.The patient is reported as doing well.
Additional Manufacturer Narrative
The involved unit was returned for investigation.A visual (macroscopic) inspection of the returned device confirmed the issue reported by the customer.The fracture characteristics observed are consistent with a ductile fracture caused by external mechanical overload, and include: - bending of the nail in the fracture region, coherent with application of an excessive external load.- rough, fibrous fracture surface.No evidence of material defect or manufacturing anomaly was observed during the macroscopic evaluation.According to the relevant instructions for use (pq fbt): "during the distraction and consolidation phase, weight bearing on the operated leg should be partial and limited to 20 kg (contact with the sole of the foot).Any exceeding load may cause the fitbone intramedullary nail to break.".
Event or Problem Description
Received information that alleged the fitbone nail broke during treatment, patient underwent a revision procedure.As per reporter, the physician does not believe the product malfunctioned, the patient experienced a fall and weightbearing may have contributed to event.The patient is reported as doing well.

• Brand Name: FITBONE TRANSPORT NAIL TN 1180-F-A-390 STERILE
• Common Device Name: FITBONE TRANSPORT NAIL TN 1180-F-A-390 STERILE
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• Manufacturer (Section G): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• Manufacturer Contact: elvira taccarelli ; via delle nazioni, 9; bussolengo, verona 37012 ; IT 37012
• MDR Report Key: 24053037
• Report Number: 9680825-2026-00002
• Device Sequence Number: 21268611
• Product Code: HSB
• UDI-Device Identifier: 18052469479858
• UDI-Public: 18052469479858
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K232169
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: FITBONE
• Device Catalogue Number: 99-60003339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2025
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male