MAUDE Adverse Event Report: Orthofix Srl FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA1180-F-245

Model Number	FITBONE
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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
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.
Event or Problem Description
As per reporter, on (b)(6) 2026 the nail was replaced.
Additional Manufacturer Narrative
Section b5 and d4 have been updated.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.

• Brand Name: FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA1180-F-245
• Common Device Name: FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA1180-F-245
• Manufacturer (Section D): Orthofix Srl; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• Manufacturer (Section G): Orthofix Srl; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• Manufacturer Contact: elvira taccarelli ; via delle nazioni, 9; bussolengo, verona 37012 ; IT 37012
• MDR Report Key: 24825651
• Report Number: 9680825-2026-00017
• Device Sequence Number: 18433831
• Product Code: HSB
• UDI-Device Identifier: 18053340343947
• UDI-Public: 18053340343947
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K163368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: FITBONE
• Device Catalogue Number: 60001404
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/13/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Supplement Date Received by Manufacturer: 03/18/2026; 03/18/2026
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 06/15/2026; 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2025
• 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