MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-KNEE ARTHROSCOPY PACK-OPC

Catalog Number	DYNJ64621C
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that extremity drape coming apart in procedure.
Additional Manufacturer Narrative
The account reported finding drape coming apart, and the complaint transcript stated that the extremity drape was coming apart in procedure.No sample or photo was received for the investigation; finished good production records, finished good pack build, and trending were reviewed.The defect was not able to be confirmed as there were no samples or detailed pictures received, and without a sample it is difficult to determine a true root cause for the reported issue.There were no issues with the build that likely contributed to the reported issue, there were 0 additional reported complaints for this issue for the account and component in the past 6 months, and the quality team 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: DBD-KNEE ARTHROSCOPY PACK-OPC
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: vamshi pinnamshetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50715041
• Report Number: 1417592-2026-35763
• Device Sequence Number: 18643324
• Product Code: OJH
• UDI-Device Identifier: 40195327525218
• UDI-Public: 40195327525218
• 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): 09/05/2026

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: DYNJ64621C
• Device Lot Number: 24ABD826
• Was Device Available for Evaluation?: No
• 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: 04/05/2024
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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