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

Model Number	SOP12KNMFM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a total knee arthroplasty procedure while implants were being placed, a light handle cover fell from one of the working overhead lights into the sterile field.Light handle cover was removed from the filed and replaced with a new cover.Surgeon aware acknowledged.Irrigated wound prior to closure.Wound class changed to contaminated.

• 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: 22839894
• Report Number: 22839894
• Device Sequence Number: 14678161
• Product Code: OJH
• UDI-Device Identifier: 10197106405864
• UDI-Public: (01)10197106405864
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2025
• Report Date (Section F): 08/14/2025

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
• Device Model Number: SOP12KNMFM
• Device Catalogue Number: SOP12KNMFM
• Device Lot Number: 480766
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/19/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2025
• 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: Unknown
• Date Report Sent to FDA: 08/14/2025