MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; FRISCO KNEE ARTHROSCOPY KIT

Catalog Number	DYNJ906498D
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "hole found in towel reinforced drape".
Additional Manufacturer Narrative
The customer reported "hole found in towel reinforced drape".A photo and a physical sample were received for one mayo stand cover; the rest of the pack was not available.Based on the information and physical sample received, the presence of a hole that punctured through the mayo stand cover was confirmed.The mayo stand cover was received in an unfolded state, making it difficult to determine whether the hole originated within the fold or on top of the surface, and with the information provided it was not able to be confirmed at what point the damage occurred.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: FRISCO KNEE ARTHROSCOPY KIT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kim evangelista ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50773060
• Report Number: 1417592-2026-40523
• Device Sequence Number: 10416628
• Product Code: OJH
• UDI-Device Identifier: 10198459117428
• UDI-Public: 10198459117428
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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 Catalogue Number: DYNJ906498D
• Device Lot Number: 25DBE367
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/30/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown