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

Catalog Number	DYNJ907170F
Medical Device Problem Code	Adhesive Too Strong (4071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coban is very sticky and hard to unwrap.
Additional Manufacturer Narrative
The account reported that the cobans having been very sticky and hard to unwrap.A sample was provided to aid in the investigation, and an unused each of component bndg cohesive 4in x 5yd was received; an attempt was made to unravel the bandage, and it was found to be difficult and if more force was used to unravel it the layers almost tore away from one another due to the adhesive.Per review of the sample provided, medline confirmed that the coban bandage was excessively difficult to unravel due to how strong the adhesive on it was.Based on the complaint details, the root cause is considered to be a vendor product issue relating to the component manufacturing process, and 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: DBD-TOTAL KNEE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sullivan bluhm ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50931949
• Report Number: 1417592-2026-52982
• Device Sequence Number: 13451655
• Product Code: OJH
• UDI-Device Identifier: 10195327658861
• UDI-Public: 10195327658861
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 09/28/2026

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: DYNJ907170F
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/16/2026
• 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: 01/09/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (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