MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC ARGYLE; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number	8888505115
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the device broke off while being used during a tka (total knee arthroplasty).Additional information received on 22aug2025 stated that it was the tip of the yankauer that broke off.It was visible in the wound and removed without complication.No intervention or treatment required.
Additional Manufacturer Narrative
The device history record (dhr) for lot 2511807564 was reviewed, and no anomalies related to the reported issue were identified.A photo was provided and upon evaluation, the reported issue was observed.However, the physical device was not returned for further investigation.Due to a delivery exception with our shipment partner, the device could not be returned for evaluation at the time of this report.If the device is received at a later date, the complaint will be reopened and updated accordingly.Based on the available information, a definitive root cause could not be determined.Therefore, no corrective actions are warranted at this time.This information will be used for tracking and trending purposes, and we will continue to monitor.

• Brand Name: ARGYLE
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 23025887
• Report Number: 1423537-2025-00360
• Device Sequence Number: 18512381
• Product Code: GCX
• UDI-Device Identifier: 10192253038972
• UDI-Public: (01)10192253038972(17)300331(10)2511807564
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2025

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 Model Number: 8888505115
• Device Catalogue Number: 8888505115
• Device Lot Number: 2511807564
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 10/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White