MAUDE Adverse Event Report: ORTHOFIX SRL CHIMAERA HFS LAG SCREW FIXED L125MM STERILE

Model Number	CHIMAERA HIP FRACTURE SYSTEM
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a surgical procedure it was not possible to remove a cephalic screw of a chimaera implant applied in (b)(6) 2024.As per reporter patient will undergo a revision procedure to remove chimaera implant.
Additional Manufacturer Narrative
The device involved in this event has not been returned for investigation, as it remains in patient.If the device is returned an investigation will be completed and a follow up report will be submitted.As per chimaera instruction for use: important- a successful result is not achieved in every surgical case.Additional complications may develop at any time due to improper use, medical reasons or device failure that require surgical re-intervention to remove or replace the internal fixation device.
Additional Manufacturer Narrative
Conclusions: the returned device has been sent back for further investigation.In addition to the nail and the fixed lag screw, the supplementary lag screw has also been returned.All components show extensive surface scratches and damage.The ends of the components are fractured, deformed, and have chipped edges.Analysis of manufacturing records confirmed that the noticed devices were released as conforming according to specifications.A review of the quality complaint database was performed, highlighting that no similar events have been registered in the last 24 months.Therefore, no trend has been identified for this type of failure.Based on all facts mentioned above, the most probable root cause of the observed damage is an unintentional user error during the tightening of the lag screw at the time of implantation.This improper handling likely resulted in mechanical stress and deformation at the screw's end, which subsequently contributed to the failure.As per chimaera instruction for use: important: a successful result is not achieved in every surgical case.Additional complications may develop at any time due to improper use, medical reasons or device failure that require surgical re-intervention to remove or replace the internal fixation device.
Event or Problem Description
It was reported that during a surgical procedure it was not possible to remove a cephalic screw of a chimaera implant applied in (b)(6) 2024.As per reporter patient will undergo a revision procedure to remove chimaera implant.As per the reporter the chimaera nail was removed; as it was not possible to disassemble the cephalic screw from the nail, they had to resect the femur.A hip prosthesis was implanted.
Additional Manufacturer Narrative
The device involved in this event was received at orthofix.The technical evaluation is ongoing.As per chimaera instruction for use: important a successful result is not achieved in every surgical case.Additional complications may develop at any time due to improper use, medical reasons or device failure that require surgical re-intervention to remove or replace the internal fixation device.
Event or Problem Description
It was reported that during a surgical procedure it was not possible to remove a cephalic screw of a chimaera implant applied in (b)(6) 2024.As per reporter patient will undergo a revision procedure to remove chimaera implant.As per the reporter the chimaera nail was removed; as it was not possible to disassemble the cephalic screw from the nail, they had to resect the femur.A hip prosthesis was implanted.

• Brand Name: CHIMAERA HFS LAG SCREW FIXED L125MM STERILE
• Common Device Name: CHIMAERA HFS LAG SCREW FIXED L125MM 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: elivra taccarelli ; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• MDR Report Key: 22466277
• Report Number: 9680825-2025-00026
• Device Sequence Number: 4121327
• Product Code: HSB
• UDI-Device Identifier: 18054242514985
• UDI-Public: 18054242514985
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K161466
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/22/2025

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 HIP FRACTURE SYSTEM
• Device Catalogue Number: 99-T93625
• Device Lot Number: R1822674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2025
• Supplement Date Received by Manufacturer: 09/24/2025; 12/22/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 10/22/2025; 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2022
• 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: 72 YR
• Patient Sex: Unknown