MAUDE Adverse Event Report: ORTHOFIX SRL CHIMAERA HFS LAG SCREW SLIDING L85MM STERILE

Model Number	CHIMAERA
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
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 fixed did not lock into the nail.A similar screw with different length was used to complete surgery.As per reporter surgical procedure was delayed by approximately 50 minutes.The patient is reported as being in observation.
Additional Manufacturer Narrative
During the investigation it was confirmed that the screw returned is a chimaera hfs lag screw sliding l85mm sterile code 99-t93785 instead of a chimaera hfs lag screw fixed l85mm sterile code 99-t93685 as initially communicated.The returned sliding lag screw underwent a visual inspection and the following was noted; no marks were observed on the screw body, confirming that the screw remained centered within the nail.Dark marks were observed along the wings, suggesting potential contact with the nail's hole.All teeth at the base were found damaged.According to the relevant operative technique, ref hf1501opt, when the lag screw is locked into the nail hole, one of the teeth located at the base of the screw engages with the corresponding tooth at the base of the nail hole, creating a blocking mechanism.Therefore, only a single tooth may potentially show marking or damage under normal engagement conditions.Analysis of the device manufacturing records confirmed that the product in question was released as conforming to the applicable specifications.Additionally, a review of the complaint database did not identify other events in which all teeth were found damaged.Even though root cause could not be confirmed, based on the investigation all teeth at the base of the lag screw were damaged as a result of potential repeated impact against the nail during the attempted engagement.No evidence of a manufacturing defect was identified, and the reported failure could be considered an isolated event.
Event or Problem Description
Received information stating that a a chimaera lag screw fixed did not lock into the nail.A similar screw with different length was used to complete surgery.As per reporter surgical procedure was delayed by approximately 50 minutes.The patient is reported as being in observation.

• Brand Name: CHIMAERA HFS LAG SCREW SLIDING L85MM STERILE
• Common Device Name: CHIMAERA HFS LAG SCREW SLIDING L85MM 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: 23606405
• Report Number: 9680825-2025-00049
• Device Sequence Number: 9259331
• Product Code: HSB
• UDI-Device Identifier: 18054242514732
• UDI-Public: 18054242514732
• 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): 03/19/2026

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-T93785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 52 KG