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

Catalog Number	DYNJ909388A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we have had over 5 instances in which the valleylab pencil (sep6000) will not work during the procedure.".
Additional Manufacturer Narrative
The account reported finding defective cautery and that the cautery would not work during the procedure; there was no report of any patient injury or adverse event.A sample was received for investigation, and medline received one used cautery pencil for sample review; the pencil tip had evidence of burning, the buttons clicked and did not stick, and there were no visual defects with the chord or plugs.The investigation and sample evaluation confirmed the reported issue.Medline determined that the root cause is a vendor product issue related to the component manufacturing process, and the vendor confirmed the reported issue through replication and determined that the device identified intermittent activation; the complaint was provided to the vendor for further evaluation and supplier quality 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: madelyn ruppert ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50760413
• Report Number: 1417592-2026-39805
• Device Sequence Number: 9415033
• Product Code: OJH
• UDI-Device Identifier: 10195327396343
• UDI-Public: 10195327396343
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: DYNJ909388A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/24/2025
• 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: 02/18/2025
• Initial Report FDA Received Date: 09/14/2026
• 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