MAUDE Adverse Event Report: ORTHOFIX SRL FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA1180-T-245

Model Number	FITBONE
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device involved in this event has not been returned for investigation,as it remains in patient.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 during treatment, a fitbone nail after 4 mm lengthening stopped distracting.Patient underwent a revision procedure.Nail was placed back in patient and will be replaced with a new nail.As per reporter patient is in good health conditions.Distributor ref: (b)(4).
Additional Manufacturer Narrative
Device involved in this event has not been returned for investigation as it remains implanted.If the device is removed and returned an investigation will be completed and a follow up report will be submitted.
Event or Problem Description
Received information that during treatment, a fitbone nail after 4mm lengthening stopped distracting.Patient underwent a revision procedure.Nail was placed back in patient and will be replaced with a new nail.As per reporter patient is in good health conditions.

• Brand Name: FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA1180-T-245
• Common Device Name: FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA1180-T-245
• 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: 22372434
• Report Number: 9680825-2025-00025
• Device Sequence Number: 19994607
• Product Code: HSB
• UDI-Device Identifier: 18053340343909
• UDI-Public: 18053340343909
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K163368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 10/20/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: FITBONE
• Device Catalogue Number: 60001348.
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2025
• 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; Other
• Patient Age: 20 YR
• Patient Sex: Female
• Patient Weight: 40 KG