MAUDE Adverse Event Report: ORTHOFIX SRL FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA0960-F-220

Model Number	FITBONE
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Insufficient Information (4580)
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 femur lengthening, the fitbone nail stopped lengthening.Patient underwent a revision procedure.
Additional Manufacturer Narrative
Analysis of manufacturing records of serial number of the nail involved, confirmed that the noticed device was released as conforming according to specifications.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.Patient underwent a revision procedure.
Additional Manufacturer Narrative
Analysis of manufacturing records for the serial number of the nail involved confirmed that the device was released as conforming according to specifications.Conclusions: the planned lengthening in one week was 7 mm (1 mm per day).The issue was identified after one week from implant.The device involved in this event has not been returned for investigation as it remains implanted.If the device is explanted and returned an investigation will be completed and a follow-up report will be submitted.
Event or Problem Description
As per reporter, initially the nail lengthened as expected, but then suddenly stopped lengthening during treatment.The patient will undergo a revision procedure.

• Brand Name: FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA0960-F-220
• Common Device Name: FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA0960-F-220
• 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: 22847493
• Report Number: 9680825-2025-00031
• Device Sequence Number: 4350395
• Product Code: HSB
• UDI-Device Identifier: 18053340344678
• UDI-Public: 18053340344678
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K203399
• 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,Followup
• Report Date (Section B): 01/20/2026

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: 60001764.
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 10/02/2025; 01/12/2026
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 10/29/2025; 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/02/2025
• 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: Unknown