MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-MK TOTAL KNEE PACK

Catalog Number	DYNJ60162C
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the light handle covers are very loose to the point the tech feels they may fall off during a case.".
Additional Manufacturer Narrative
It was reported that the light handle covers loose; the customer email stated they appear to be much more slippery than they used to be and there were concerns of contamination as they slip off easily when using them and may slip off on their own.No sample or photo was received for the investigation; finished good production records were reviewed and there are no "light handle covers" that were picked or placed in this pack, and the finished good pack build was reviewed and there are no "light handle covers" in the bill of materials.Based on the review of the details provided for the complaint investigation, that the product failed to meet specifications; the cause code was adjusted to unconfirmed defect with item not in kit bom.Complaints are monitored via the trend analysis procedure, and if a sample, photo and/or additional information becomes available this complaint will be reopened to be further investigated.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-MK TOTAL KNEE PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkat gaanuthula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50820062
• Report Number: 1417592-2026-44854
• Device Sequence Number: 15991929
• Product Code: OJH
• UDI-Device Identifier: 40195327020805
• UDI-Public: 40195327020805
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 09/17/2026

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: DYNJ60162C
• Device Lot Number: 22KBD071
• Was Device Available for Evaluation?: Yes
• 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: 01/10/2023
• Initial Report FDA Received Date: 09/18/2026
• 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