MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. COMPONENT KIT; LAVAGE, JET

Catalog Number	00515042000
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under: (b)(4).E1 phone number: (b)(6).G2 foreign: republic of korea.The investigation is complete.This is an initial final report submission.Functional testing of the returned product found the device would not power on with the original battery pack nor when connected to a lab battery pack.Visual inspection of the interior of the pack found the batteries had leaked electrolyte inside of the pack.There did not appear to be damage to the wiring of the pack.Visual inspection of the interior of the handpiece found the plunger was stuck in place inside the plunger housing.The motor would power on when the electrodes were made to touch in both trigger modes when connected to the lab battery pack.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The event is confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that during surgery the pulsavac device would power on but would not work.The battery was replaced but still would not work.There was no report of harm or delay.Diligence is complete.No additional information is available.During device evaluation visual inspection of the interior of the pack found the batteries had leaked electrolyte inside of the pack.No adverse events were reported as a result of this malfunction.

• Brand Name: COMPONENT KIT
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21432345
• Report Number: 0001526350-2025-00227
• Device Sequence Number: 17271312
• Product Code: FQH
• UDI-Device Identifier: 00889024375123
• UDI-Public: (01)00889024375123(17)261213(10)73890747
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2025

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 Catalogue Number: 00515042000
• Device Lot Number: 73890747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Prefer Not To Disclose