MAUDE Adverse Event Report: ORTHOFIX SRL FITBONE TRANSPORT NAIL TN 1160-F-A-390 STERILE

Model Number	FITOBONE
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/20/2026
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.
Event or Problem Description
Received information that an alleged ftibone transport nail stopped working during treatment.Patient underwent a revision procedure.

• Brand Name: FITBONE TRANSPORT NAIL TN 1160-F-A-390 STERILE
• Common Device Name: FITBONE TRANSPORT NAIL TN 1160-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, italy 37012 ; IT 37012
• MDR Report Key: 24663771
• Report Number: 2183449-2026-00009
• Device Sequence Number: 14712869
• Product Code: HSB
• UDI-Device Identifier: 18052469479780
• UDI-Public: 18052469479780
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K232169
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/23/2026

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: FITOBONE
• Device Catalogue Number: 99-60003332
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female