MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; NHS- KNEE GNG WCG

Catalog Number	DYNJ39906
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer contact, on (b)(6) 2025, the lap sponges in the knee pack "started to disintegrate while inside the patient.
Additional Manufacturer Narrative
According to the customer contact, on (b)(6) 2025, the lap sponges in the knee pack "started to disintegrate while inside the patient.The small fragments had to be manually removed by the surgeon." it was confirmed it was the "white part of the sponge that was falling apart, not the blue x-ray tag." no serious injury or further medical intervention beyond manual removal was reported.No additional information at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: MEDLINE
• Common Device Name: NHS- KNEE GNG WCG
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; 3 lakes dr; northfield IL 60093
• Manufacturer Contact: alyssa reasner ; 3 lakes dr; northfield, IL 60093
• MDR Report Key: 23795299
• Report Number: 1423395-2025-00201
• Device Sequence Number: 10476938
• Product Code: OJH
• UDI-Device Identifier: 10884389846735
• UDI-Public: 10884389846735
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ39906
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown