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

Model Number	FITBONE
Medical Device Problem Codes	Mechanical Problem (1384); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
As per reporter, during treatment for femur lengthening, the fitbone nail stopped lengthening.As per reporter the patient will undergo a revision procedure.
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 femur lengthening, the fitbone nail stopped lengthening.As per reporter the patient will undergo a revision procedure.Further information received: as per the reporter during a revision surgery on (b)(6) 2025, the nail was replaced with another nail.
Additional Manufacturer Narrative
Device involved in this event has been returned for investigation.The technical analysis is currently on going.As soon as it is completed a follow up report will be submitted.
Event or Problem Description
As per reporter, during treatment for femur lengthening, the fitbone nail stopped lengthening.As per reporter the patient will undergo a revision procedure.Further information received: as per the reporter during a revision surgery on (b)(6) 2025, the nail was replaced with another nail.
Additional Manufacturer Narrative
The unit was returned with the receiver, and dimensional verification confirmed that the maximum achieved lengthening was 4.5 mm over a period of approximately one month.During functional testing, the alleged event was confirmed.Although the motor functional parameters (including no-load current consumption) were within the specified limits, no lengthening movement could be observed.Further sectioning of the nail was performed before the motor-lead screw interface, revealing that the seeger was disengaged.This condition resulted in a loss of mechanical engagement between the motor and the lead screw assembly, preventing the lead screw from advancing and consequently inhibiting the lengthening mechanism.A review of the manufacturing records confirmed that the devices were released as conforming to all applicable specifications.

• 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: 23540202
• Report Number: 9680825-2025-00044
• Device Sequence Number: 9457997
• Product Code: HSB
• UDI-Device Identifier: 18053340344067
• UDI-Public: 18053340344067
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K163368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup
• Report Date (Section B): 02/23/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: FITBONE
• Device Catalogue Number: 60001468.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: 01/19/2026; 02/18/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 02/17/2026; 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2023
• 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 Age: 17 YR
• Patient Sex: Male
• Patient Weight: 75 KG