MAUDE Adverse Event Report: Orthofix Srl FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA0960-F-220

Model Number	FITBONE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Received information of an issue during implantation of a fitbone nail.As per reporter, during distal screw locking, the maximum available orthofix 4.0 mm locking screw was insufficient to achieve both secure fixation and maintain transport mechanism functionality.The surgeon implanted a third-party 4.0mm ø steinman-pin (steel).Allegedly, this led to a surgery delay of 60-90 minutes.The patient is stable and in good health.The receiver and control unit have been tested positive after implantation.No allegation of product malfunction was reported by the user.
Additional Manufacturer Narrative
No allegation of product malfunction was reported by user.Precautions from relevant instructions for use: fitbone devices should be used together with their corresponding fitbone implants, components, accessories and instrumentation following the operative technique recommended by the manufacturer.Orthofix does not guarantee the safety and effectiveness of the fitbone when used in conjunction with other orthofix devices if not specifically indicated in the operative technique.

• 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, 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: 50515262
• Report Number: 9680825-2026-00048
• Device Sequence Number: 9375806
• 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
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: FITBONE
• Device Catalogue Number: 60001764.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 14 YR
• Patient Sex: Female