MAUDE Adverse Event Report: ORTHOFIX SRL CHIMAERA HFS LAG SCREW SLIDING L110MM STERILE

Model Number	CHIMAERA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/03/2025
Type of Reportable Event	Malfunction
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
Received information stating that a chimaera lag screw sliding did not lock into the nail.A portion of the screw broke off inside the patient.Device fragments were left in patient.
Event or Problem Description
Received information stating that a chimaera lag screw sliding did not lock into the nail.A portion of the screw broke off inside the patient.As per reporter device fragments were left in patient.
Additional Manufacturer Narrative
Technical analysis: the unit was returned for investigation, which confirmed fracture of the ferrule wings.Visual inspection identified, the ferrule exhibited distal migration, resulting in exposure of the reduced-diameter section of the lag screw's central body and the teeth showed evidence of chipping and localized material loss.It was not possible to perform a functional check due to the deformation of the screw.Analysis of manufacturing records confirmed that the noticed device was released as conforming according to specifications.A review of the quality complaint database was performed, confirming that no similar events have been registered in the last 24 months.Therefore, no trend has been identified for this type of failure, indicating that this event is isolated.Conclusions based on all facts mentioned above, it cannot be excluded that the reported failure was due to a mechanical obstruction preventing the lag screw from advancing to its intended position, causing it to become jammed against the wings.The distal section of the lag screw body showed more pronounced superficial marks, supporting this hypothesis.Even though root cause cannot be confirmed, the mechanical obstruction 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 L110MM STERILE
• Common Device Name: CHIMAERA HFS LAG SCREW SLIDING L110MM 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: 22828019
• Report Number: 9680825-2025-00027
• Device Sequence Number: 4463920
• Product Code: HSB
• UDI-Device Identifier: 18054242514787
• UDI-Public: 18054242514787
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K161466
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/19/2026

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: CHIMAERA
• Device Catalogue Number: 99-T93710
• Device Lot Number: B5410764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown