MAUDE Adverse Event Report: ORTHOFIX SRL FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA1380-F-245

Model Number	FITBONE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Loss of fracture reduction (4901)
Date of Event	02/06/2026
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
Received information stating that a fitbone nail broke during treatment.On (b)(6) 2026, patient underwent a revision procedure to remove the nail.
Additional Manufacturer Narrative
The returned device, received on march 11, 2026 is currently under technical investigation.A follow up report will be provided as soon as the results of the technical investigation are available.
Event or Problem Description
Received information stating that a fitbone nail broke during treatment.On (b)(6) 2026, patient underwent a revision procedure to remove the nail.Further information received on (b)(6) 2026: batch number of the fitbone nail which broke: b5157349, date of initial surgery: (b)(6) 2025 date of awareness of the problem: 19/05/2025, weight of the patient: around 75 kg.The nail and the broken portion were completely removed from the patient during the surgical revision done on (b)(6).
Event or Problem Description
Received information stating that a fitbone nail broke during treatment.On (b)(6) 2026, patient underwent a revision procedure to remove the nail.Further information received on february 23, 2026: batch number of the fitbone nail which broke: b5157349 date of initial surgery: (b)(6)2025 date of awareness of the problem: 19/05/2025 weight of the patient : around 75 kg the nail and the broken portion were completely removed from the patient during the surgical revision done on (b)(6).
Additional Manufacturer Narrative
Technical analysis the unit returned for further investigation and macroscopic analysis confirmed the alleged event.Visual inspection identified that the fracture occurred at the distal tip of the nail, specifically at the screw hole, which represents stress concentration area.Macroscopic morphology is consistent with a ductile overload malfunction, with plastic collapse prior to final separation.Even though root cause cannot be confirmed, it is believed the fracture may have initiated at the edge of the locking hole and propagated under high local stress, leading to final failure under bending and/or tensile loading conditions.Analysis of manufacturing records confirmed that the noticed device was released as conforming according to specifications.The database review was performed, and no trend has been identified.

• Brand Name: FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA1380-F-245
• Common Device Name: FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA1380-F-245
• 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: 24399562
• Report Number: 9680825-2026-00009
• Device Sequence Number: 8299633
• Product Code: HSB
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K163368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2026

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: 60001422.
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 02/23/2026; 06/19/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/19/2026; 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2024
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 165 LB