MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. PULSAVAC®; LAVAGE, JET

Model Number	00-5150-183-00
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
While irrigating the femoral canal of the patient the end of the brush tip broke off into the canal.Laparoscopic grasper was used to retrieve the broken piece from the canal.

• Brand Name: PULSAVAC®
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio ave; dover OH 44622
• MDR Report Key: 22518671
• Report Number: 22518671
• Device Sequence Number: 7951340
• Product Code: FQH
• UDI-Device Identifier: 00889024374973
• UDI-Public: (01)00889024374973(17)280329(10)81839892
• 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): 07/14/2025
• Report Date (Section F): 07/14/2025

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
• Operator of Device: Health Professional
• Device Model Number: 00-5150-183-00
• Device Catalogue Number: 00-5150-183-00
• Device Lot Number: 81839892
• 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: 07/16/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/16/2025
• 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: 51 YR
• Patient Sex: Male
• Patient Weight: 134 KG
• Date Report Sent to FDA: 07/14/2025