MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; ORTHOPEDIC TRAY

Model Number	SOPDHCJWKB
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During initial exposure on total knee arthroplasty, a #10 blade snapped into two pieces while being used.The bottom portion was returned on the knife handle, and the blade was retrieved by the surgeon from inside the patient's knee.

• Brand Name: CARDINAL HEALTH
• Common Device Name: ORTHOPEDIC TRAY
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 22977021
• Report Number: 22977021
• Device Sequence Number: 15687971
• Product Code: OJH
• UDI-Device Identifier: 10197106651780
• UDI-Public: (01)10197106651780
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/29/2025
• Report Date (Section F): 08/29/2025

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: SOPDHCJWKB
• Device Catalogue Number: SOPDHCJWKB
• Device Lot Number: 494862
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/05/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/05/2025
• 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: Male
• Date Report Sent to FDA: 08/29/2025