MAUDE Adverse Event Report: ORTHOFIX SRL FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA0940-F-200

Model Number	FITBONE
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Implant Pain (4561)
Type of Reportable Event	Serious Injury
Event or Problem Description
Received information stating patient was hospitalized due to increased pain post lengthening.As per reported radiographic inspection identified excessive elongation.Patient has been released from hospital.Manufacturer ref: (b)(4).Distributor reference: (b)(4).
Additional Manufacturer Narrative
As per reporter the surgeon reported difficulties with the control set since the first lengthening session.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.As per ifu: possible adverse events.In addition to the general risks involved in surgical intervention, the following side effects may occur in some cases despite correct treatment: slight tingling to severe pain in the affected limb, particularly during and after distraction.
Additional Manufacturer Narrative
Technical analysis and conclusions: a technical evaluation of the device involved was not possible as it was not returned for analysis.Based on the information provided: 1) the nail and receiver are implanted and functioning.2) the control set is with the patient, and it is functioning.3) the patient is continuing the treatment successfully.It is likely that there was no malfunction or deterioration in the device performance and that the issue experienced is not device-related.As per ifu: possible adverse events.In addition to the general risks involved in surgical intervention, the following side effects may occur in some cases despite correct treatment: · slight tingling to severe pain in the affected limb, particularly during and after distraction.
Event or Problem Description
Received information stating patient was hospitalized due to increased pain post lengthening.As per reported radiographic inspection identified excessive elongation.Patient has been released from hospital.Manufacturer ref: (b)(4).Distributor reference: (b)(4).

• Brand Name: FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA0940-F-200
• Common Device Name: FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA0940-F-200
• 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: gianluca ricadona ; via delle nazioni, 9; bussolengo, verona 37012 ; IT 37012
• MDR Report Key: 21815001
• Report Number: 9680825-2025-00014
• Device Sequence Number: 15280585
• Product Code: HSB
• UDI-Device Identifier: 18053340345347
• UDI-Public: 18053340345347
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K203399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/26/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: FITBONE
• Device Catalogue Number: 60001921
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Supplement Date Received by Manufacturer: 05/26/2025
• Initial Report FDA Received Date: 04/10/2025
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2024
• 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: Hospitalization
• Patient Age: 15 YR
• Patient Sex: Female
• Patient Weight: 45 KG