MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; WC, K3, 18", SB HARDLA, SA

Catalog Number	K3186N34S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the two big wheels are broken.".
Additional Manufacturer Narrative
The customer stated that "the two big wheels are broken," the issue did not occur during use, and no injury occurred.A photo depicting the defect was provided and only a visual review of the defect could be conducted; a physical sample was not provided, and a functional or dimensional inspection could not be executed via a photo.The investigation results were confirmed: the left and right rear wheels are fractured, with the left rear wheel appearing to have fractured spokes and the right rear wheel appearing fractured on the outer perimeter, spokes, and the hand rim.The product appeared to be in new condition due to the wheels still wrapped in packaging plastic; therefore, this issue is most likely due to shipping damage, and the division will monitor through trending.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: WC, K3, 18", SB HARDLA, SA
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: connor klawikowski ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50884639
• Report Number: 1417592-2026-50050
• Device Sequence Number: 13450450
• Product Code: IOR
• UDI-Device Identifier: 10193489083699
• UDI-Public: 10193489083699
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K990463
• 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): 09/23/2026

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: K3186N34S
• Device Lot Number: EA250900537
• 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: 12/17/2025
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown