MAUDE Adverse Event Report: ORTHOFIX SRL CHIMAERA HFS LAG SCREW SLIDING L95MM 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
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.
Event or Problem Description
Received information stating that after a month from application, a chimaera lag screw sliding backed out from the nail.A revision surgery was necessary to replace the implant.The patient is well.
Event or Problem Description
Received information stating that after a month from application, a chimaera lag screw sliding backed out from the nail.A revision procedure was necessary to replace the implant.As per reporter, patient is well.
Additional Manufacturer Narrative
Technical analysis the returned devices have been sent back for further investigation.In addition to the lag screw sliding, the nail has also been returned.During the investigation it was identified that the lag barrel of the lag screw has several superficial marks on the central area; however, the wings and teeth were intact and showed minimal signs of use.It was identified that the lag barrel and the inner screw were found to be completely detached.It was not possible to perform the functional check as the screw is deformed.Analysis of manufacturing records confirmed that the noticed devices were released as conforming according to specifications.A review of the cases was conducted, confirming that no similar complaints have been recorded in the past 24 months.Therefore, no trend has been identified for this type of failure, and no corrective action was issued.This can be considered as an isolated event.Conclusions as per product design, once the screw teeth engage with the nail, the wings of the screw are deployed, generating a radial pressure.In the reported event, it cannot be ruled out that the wings were only partially deployed.The surface of the wings showed no advancement and no signs of contact or interaction with the nail hole.Even though root cause cannot be confirmed, based on the findings this may be attributable to external factors, rather than being device related.

• Brand Name: CHIMAERA HFS LAG SCREW SLIDING L95MM STERILE
• Common Device Name: CHIMAERA HFS LAG SCREW SLIDING L95MM 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 37012 ; IT 37012
• MDR Report Key: 22901926
• Report Number: 9680825-2025-00032
• Device Sequence Number: 9089117
• Product Code: HSB
• UDI-Device Identifier: 18054242514756
• UDI-Public: 18054242514756
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 01/16/2026

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-T93795
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male