MAUDE Adverse Event Report: Orthofix Srl FITBONE TRANSPORT NAIL TN 1140-T-310 STERILE

Model Number	FITBONE
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Received information that alleged the fitbone nail stop working during treatment, patient underwent a revision procedure.
Additional Manufacturer Narrative
The returned device, received on (b)(6) 2026 is currently under technical investigation.A follow up report will be provided as soon as the results of the technical investigation are available.

• Brand Name: FITBONE TRANSPORT NAIL TN 1140-T-310 STERILE
• Common Device Name: FITBONE TRANSPORT NAIL TN 1140-T-310 STERILE
• 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: 50768724
• Report Number: 9680825-2026-00052
• Device Sequence Number: 10416493
• Product Code: HSB
• UDI-Device Identifier: 18052469479384
• UDI-Public: 18052469479384
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K232169
• 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): 09/14/2026

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: 99-60003292
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/04/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2026
• 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