MAUDE Adverse Event Report: ORTHOFIX SRL ULTRASONIC GENERATOR 230V

Model Number	OSCAR
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Received information that alleged the oscar 3 generator malfunction during surgery.The penetration of the femur cortex occurred.No other details were provided.
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.

• Brand Name: ULTRASONIC GENERATOR 230V
• Common Device Name: ULTRASONIC GENERATOR 230V
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• Manufacturer (Section G): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• Manufacturer Contact: elvira taccarelli ; via delle nazioni, 9; bussolengo, verona 37012 ; IT 37012
• MDR Report Key: 24658303
• Report Number: 9680825-2026-00013
• Device Sequence Number: 9243272
• Product Code: JDX
• UDI-Device Identifier: 18056099649971
• UDI-Public: 18056099649971
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K093805
• 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): 06/12/2026

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: OSCAR
• Device Catalogue Number: OS3000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 03/22/2026
• Supplement Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female