MAUDE Adverse Event Report: ORTHOFIX SRL CHIMAERA HFS LAG SCREW SLIDING L90MM STERILE

Model Number	CHIMAERA
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a portion of a chimaera screw implanted on (b)(6) 2025, disengaged during treatment.Patient underwent a revision procedure on (b)(6) 2026.
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.
Event or Problem Description
It was reported that a portion of a chimaera screw implanted on (b)(6) 2025, disengaged during treatment.Patient underwent a revision procedure on (b)(6) 2026.
Additional Manufacturer Narrative
Technical analysis and conclusions.The device involved was returned for investigation.The x-ray provided showed an apparent detachment between the lag barrel and the inner screw.However, the two aforementioned components were not found to be disassembled.A metallic filament, foreign to the device, was identified in the distal portion.Moreover, the lag barrel of the lag screw was found to have several superficial marks on its central area; however, the wings and teeth were intact and showed minimal signs of use.Based on visual inspection, no markings or evidence of engagement were observed on either of the teeth.Even though root cause cannot be confirmed it is believed that incomplete mechanical locking is likely attributable to external factors, rather than being device-related.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.

• Brand Name: CHIMAERA HFS LAG SCREW SLIDING L90MM STERILE
• Common Device Name: CHIMAERA HFS LAG SCREW SLIDING L90MM 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: 24567807
• Report Number: 9680825-2026-00010
• Device Sequence Number: 8366703
• Product Code: HSB
• UDI-Device Identifier: 18054242514749
• UDI-Public: 18054242514749
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K161466
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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): 06/18/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CHIMAERA
• Device Catalogue Number: 99-T93790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2025
• 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 Age: 78 YR
• Patient Sex: Female