MAUDE Adverse Event Report: Orthofix Srl FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA1160-F-225

Model Number	FITBONE
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury

• 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, 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: 50879073
• Report Number: 9680825-2026-00055
• Device Sequence Number: 10714951
• Product Code: HSB
• UDI-Device Identifier: 18053340344067
• UDI-Public: 18053340344067
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K163368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: FITBONE
• Device Catalogue Number: 60001468.
• 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: 09/02/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2025
• 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