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

Catalog Number	K3166N34S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "wheelchair.Broken right out of the box.".
Additional Manufacturer Narrative
The customer reported via email that the wheelchair was "broken right out of the box," and information and photos provided by the customer indicated the wheelchair has a cracked rear wheel.A physical sample was not provided; a photo depicting the defect was provided and only a visual review of the defect could be conducted, and after reviewing the photo it was discovered that the rear wheel spokes appear to be fractured around the hub.The investigation results were confirmed.The product appeared to be in new condition; therefore, this issue is most likely due to shipping damage, with cause code updated to "dc:unknown responsible party - mishandling: by mfg.Or can't determine," and there has been no change to the reportability decision associated with this complaint.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, SA
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: haroon mian ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50898070
• Report Number: 1417592-2026-50954
• Device Sequence Number: 18812521
• Product Code: IOR
• UDI-Device Identifier: 00193489083678
• UDI-Public: 00193489083678
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 09/24/2026

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: K3166N34S
• Device Lot Number: 16424060002
• 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: 10/02/2024
• Initial Report FDA Received Date: 09/25/2026
• 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