MAUDE Adverse Event Report: ORTHOFIX SRL SCREW EXTRACTOR SIZE 4 - 9MM

Model Number	CHIMAERA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
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 during the removal of a chimaera nail, the nail extractor broke inside the cephalic screw.This led to an extension of surgery time of two hours.The patient is in good condition.
Additional Manufacturer Narrative
Technical analysis and conclusions it was reported that the extractor was found broken inside the lag screw during the removal of a chimaera nail.X ray images were provided as evidence of the defect.The returned units included the extractor, the lag screw, and the nail.Visual inspection confirmed the fracture of the extractor tip, which remained stuck inside the lag screw.Although inspection of the lag screw suggested that the diameter of the fragment retained inside appeared larger than the nominal diameter of the extractor tip, this was likely influenced by deformation and damage.Both the nail and the lag screw were returned severely damaged; however, this condition may be attributable to the explantation handling performed due to the inability to disengage the lag screw from the nail.According to the relevant instructions for use hf1501opt (nail extractor), the removal of the lag screw can be performed using the screw extractor connected via the universal chuck with t handle, applying a counter clockwise movement until the lag screw is removed.In the reported case, it cannot be excluded that the counter clockwise movement was impeded, most likely due to an inadequate connection.As a consequence, the lag screw wings may not have been properly deployed, and the application of excessive force during the extraction handling likely resulted in the fracture of the extractor.This was supported by the macroscopic fracture analysis of the steel extractor, which showed a large, opaque, and rough fracture surface, indicative of failure under very high applied load (high stress conditions).No similar cases have been reported in the last 24 months; therefore, this event can be considered isolated.
Event or Problem Description
Received information stating that during the removal of a chimaera nail, the nail extractor broke inside the cephalic screw.This led to an extension of surgery time of two hours.The patient was reported in good condition.

• Brand Name: SCREW EXTRACTOR SIZE 4 - 9MM
• Common Device Name: SCREW EXTRACTOR SIZE 4 - 9MM
• 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: 23875741
• Report Number: 9680825-2025-00054
• Device Sequence Number: 12149123
• Product Code: HSB
• UDI-Device Identifier: 18056099649216
• UDI-Public: 18056099649216
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 04/23/2026

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: 193337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Other
• Patient Age: 49 YR
• Patient Sex: Female