MAUDE Adverse Event Report: Orthofix Srl SCREW EXTRACTOR SIZE 4 - 9MM

Model Number	CHIMAERA
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
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.
Event or Problem Description
Received information stating that during removal of a chimaera implant, the nail extractor got cross threaded in the lag screw.It was possible to finalize the surgery, with a delay of 30 minutes.Patient/user not affected.
Event or Problem Description
Received information stating that during removal of a chimaera implant, the nail extractor got cross threaded in the lag screw.It was possible to finalize the surgery, with a delay of 30 minutes.Patient/user not affected.
Additional Manufacturer Narrative
It was reported that the extractor was found cross threaded inside the lag screw during the removal of a chimaera nail.Despite making multiple good faith efforts to follow up with the reporter, no additional details regarding the event were provided.The affected unit was not returned and, therefore, was unavailable for further investigation at the manufacturing site.A review of the complaint database identified one similar case within the last 24 months.No specific action was currently deemed necessary, orthofix maintains and documents periodic customer events monitoring process in order to evaluate actions for products improvement.

• 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: 24909536
• Report Number: 9680825-2026-00018
• Device Sequence Number: 9874662
• Product Code: HSB
• UDI-Device Identifier: 18056099649216
• UDI-Public: 18056099649216
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161466
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2026

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: 193337
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown