MAUDE Adverse Event Report: ORTHOFIX SRL CHIMAERA HFS LONG NAIL LEFT 125° L420MM D10MM STERILE

Model Number	CHIMAERA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Received information stating that a chimaera nail broke inside of the patient.Patient underwent a revision procedure.
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.General precautions from the relevant instructions for use: it is surgeon's responsibility to select optimal type, size and position of nail and screws according to the fracture pattern and patient characteristics.Improper positioning of nail and screws may result in loosening, bending, cracking, or fracture of the device or bone or both.
Additional Manufacturer Narrative
It was reported that a chimaera nail, fractured approximately two months after surgery.The issue was confirmed through x ray images provided by the customer and by visual inspection performed upon return of the device to the manufacturer.Visual inspection also revealed ovalization of the nail hole where the lag screw was inserted.Review of manufacturing records confirmed that the device was released as conforming to specifications.Analysis of similar complaints did not identify comparable events, supporting the conclusion that this is an isolated occurrence.No specific corrective actions were deemed necessary.Orthofix continues to maintain and document periodic monitoring of customer events to evaluate potential product improvement actions.
Event or Problem Description
Received information stating that a chimaera nail broke inside of the patient.Patient underwent a revision procedure.

• Brand Name: CHIMAERA HFS LONG NAIL LEFT 125° L420MM D10MM STERILE
• Common Device Name: CHIMAERA HFS LONG NAIL LEFT 125° L420MM D10MM STERILE
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• Manufacturer (Section G): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• Manufacturer Contact: elvira taccarelli ; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• MDR Report Key: 24077788
• Report Number: 9680825-2026-00001
• Device Sequence Number: 9997248
• Product Code: HSB
• UDI-Device Identifier: 18033509852046
• UDI-Public: 18033509852046
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K173458
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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: CHIMAERA
• Device Catalogue Number: 99-T932422L
• Device Lot Number: B1251653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2018
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 80 KG