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	01/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During opening of sterile field, it was noted the sterile supply pack had multiple areas that looked like piercings through the internal wrap layer.There were areas of distress on the outer layer, but no areas showed piercing or tearing.New supply pack was obtained.Item: sop12knmfm, exp: 07/01/2027, lot: 638489.

• 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: 24188099
• Report Number: 24188099
• Device Sequence Number: 15486735
• 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): 01/13/2026
• Report Date (Section F): 01/13/2026

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
• Device Model Number: SOP12KNMFM
• Device Catalogue Number: SOP12KNMFM
• Device Lot Number: 638489
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/27/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2026
• 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: 01/13/2026