MAUDE Adverse Event Report: ORTHOFIX SRL FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA1160-F-225

Model Number	FITBONE
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/04/2025
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.
Event or Problem Description
Received information stating that a fitbone nail broke during treatment.Patient underwent a revision procedure that extended the surgical procedure.
Event or Problem Description
Received information stating that a fitbone nail broke during treatment.Patient underwent a revision procedure that extended the surgical procedure.
Additional Manufacturer Narrative
A technical evaluation of the device involved in this event was not possible as it was not returned for analysis.Based on the information available on the event, it was not possible to finalize the investigation and determine the root cause of the problem complained.If the device is returned an investigation will be completed and a follow up report will be submitted.

• Brand Name: FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA1160-F-225
• Common Device Name: FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA1160-F-225
• 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: 22295867
• Report Number: 9680825-2025-00023
• Device Sequence Number: 15685861
• Product Code: HSB
• UDI-Device Identifier: 18053340344067
• UDI-Public: 18053340344067
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K163368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 08/26/2025

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: 60001468.
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2024
• 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: 18 YR
• Patient Sex: Male