MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. KAMVAC; CATHETER AND TIP, SUCTION

Model Number	5300-20-500
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The suction broke into several pieces during use at the sterile field.

• Brand Name: KAMVAC
• Common Device Name: CATHETER AND TIP, SUCTION
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 24828686
• Report Number: 24828686
• Device Sequence Number: 15758583
• Product Code: JOL
• UDI-Device Identifier: 10603295171515
• UDI-Public: (01)10603295171515(17)300429(10)1023982
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/06/2026
• Report Date (Section F): 04/06/2026

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
• Operator of Device: Health Professional
• Device Model Number: 5300-20-500
• Device Catalogue Number: 530020500
• Device Lot Number: 1023982
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/09/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Date Report Sent to FDA: 04/06/2026