MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; WC, K3, 16", SB HARDLA, ELR

Catalog Number	K3166N34E
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the frame broke above the left wheel axle when the end user was in the wheelchair.".
Additional Manufacturer Narrative
The customer stated that the frame broke above the left wheel axle when the end user was in the wheelchair; no injury was reported.A physical sample was not provided; a photo depicting the defect was provided and only a visual review of the defect can be conducted, and after reviewing the photos, it was discovered that the frame tubing appears to be fractured directly below the upper hemi height axle hole and above the lower hemi height axle hole, at the location where the rear wheel axle would pass through the tubing.Investigation results were confirmed.Given the evidence provided in the photo, as well as the incident report, the root cause of the reported issue cannot be determined at this time, and the division will monitor complaints through quarterly 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, 16", SB HARDLA, ELR
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: jarred meyers ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50917023
• Report Number: 1417592-2026-52260
• Device Sequence Number: 5330528
• Product Code: IOR
• UDI-Device Identifier: 00193489083661
• UDI-Public: 00193489083661
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 09/25/2026

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: K3166N34E
• 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: 03/25/2026
• Initial Report FDA Received Date: 09/28/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown