MAUDE Adverse Event Report: ORTHOFIX SRL ORTHOFIX FITBONE FEMORAL BONE TRANSPORT NAIL; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	60001780
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Internal bone transport nail motor failed halfway through bone transport requiring additional surgery, additional anesthesia and increased risk for infection.Required to remove intramedullary nail and place new intramedullary nail.Multiple consecutive xrays confirmed failure of bone transport nail movement.

• Brand Name: ORTHOFIX FITBONE FEMORAL BONE TRANSPORT NAIL
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ORTHOFIX SRL
• MDR Report Key: 24702055
• Report Number: MW5185957
• Device Sequence Number: 5763455
• Product Code: HSB
• UDI-Device Identifier: 18053340344692
• UDI-Public: 18053340344692
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 60001780
• Device Lot Number: B5276510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/26/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 867 KG
• Patient Race: White