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

Catalog Number	K3166N44E
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "black clip broke and the armrest falls onto the floor because it is no longer attached.".
Additional Manufacturer Narrative
The customer states black clip broke and the armrest falls onto the floor because it is no longer attached, and when the attached arm rest falls over the customer is not able to bring it back up and needs to wait until assistance is requested; no injury occurred.A physical sample was not provided, and a photo depicting the defect was provided; photo one depicts the left-side armrest pivot holster and photo two shows the right-side armrest pivot holster.Investigation results were not confirmed: there is no visible indication of a fracture, no bending or fractures can be confirmed, and the issue cannot be identified based on the photos provided.No root cause was identified, and the result will be incorporated into monthly and 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 HARFLA, ELR
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: rahul kota ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50869670
• Report Number: 1417592-2026-48919
• Device Sequence Number: 15759065
• Product Code: IOR
• UDI-Device Identifier: 00193489088192
• UDI-Public: 00193489088192
• 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): 09/22/2026

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: K3166N44E
• Device Lot Number: 16424010001
• 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: 12/31/2025
• Initial Report FDA Received Date: 09/23/2026
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown