MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TOTAL KNEE CKHA-LF

Catalog Number	DYNJ41756G
Medical Device Problem Codes	Material Perforation (2205); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "there was a tear in the drape upon opening- the drape was unable to be used".
Additional Manufacturer Narrative
The customer reported there was a tear in the drape upon opening and the drape was unable to be used; the issue did not occur during use and no injury occurred.A photo and a sample were received for investigation, and the sample received consisted of the pack insert, pouch, and back table cover; examination of the pouch showed no damage.A large tear was observed in the back table cover, confirming the issue reported by the account.The back table cover was found to be torn and perforated, consistent with contact with an external source, and the investigation is unable to determine at what point during production, transit, or storage the damage occurred; the division will monitor this issue for trending purposes.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: TOTAL KNEE CKHA-LF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: vamshi thupakula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50734589
• Report Number: 1417592-2026-37045
• Device Sequence Number: 10661991
• Product Code: OJH
• UDI-Device Identifier: 10888277776807
• UDI-Public: 10888277776807
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 09/08/2026

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: DYNJ41756G
• Device Lot Number: 25IBT455
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/31/2026
• 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: 01/26/2026
• Initial Report FDA Received Date: 09/11/2026
• 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