MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC.; ORTHOPEDIC TRAY

Model Number	DYNJ33650O
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During setup of the sterile back table, a short brown hair was discovered on the sterile light handle contained in the lower extremity pack.As a result, the entire back table was deemed contaminated.All supplies were discarded or replaced, and all instruments required decontamination and re-sterilization, causing a delay in the procedure.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: ORTHOPEDIC TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 24002583
• Report Number: 24002583
• Device Sequence Number: 10503210
• Product Code: OJH
• UDI-Device Identifier: 10198459480973
• UDI-Public: (01)10198459480973
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/30/2025
• Report Date (Section F): 12/30/2025

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: DYNJ33650O
• Device Catalogue Number: DYNJ33650O
• Device Lot Number: 25JMB549
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 01/08/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2026
• 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: 12/30/2025