MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; WC, XW, 26", RDLA, SA, 500 LB

Catalog Number	KX268V21S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the wheel was sightly off" and "the wheel being broken was noticed due to a clicking sound it was making while rolling"."the spoke of the wheel is broken.".
Additional Manufacturer Narrative
The customer stated the wheel was sightly off, the wheel being broken was noticed due to a clicking sound it was making while rolling, and the spoke of the wheel is broken.A physical sample was not provided; a photo depicting the defect was provided and only a visual review of the defect could be conducted.Investigation results were confirmed, and after reviewing the photo, it was discovered that a spoke on the right rear wheel fractured off the wheel hub and was out of alignment.The issue was most likely due to shipping damage, and the cause code was updated to supplier error asia (medline brand) - mfg: material composition; 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, XW, 26", RDLA, SA, 500 LB
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: diana arizmendi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50946337
• Report Number: 1417592-2026-54230
• Device Sequence Number: 16063843
• Product Code: IOR
• UDI-Device Identifier: 00193489179968
• UDI-Public: 00193489179968
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 09/29/2026

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: KX268V21S
• 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: 11/13/2024
• Initial Report FDA Received Date: 09/30/2026
• 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