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

Catalog Number	00515042000
Medical Device Problem Codes	Failure to Power Up (1476); Material Deformation (2976); Powder Leak (4069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the new pulsavac kit battery pack appeared to be miss-shaped and the device would not power on.When the battery pack was opened, it was found that the batteries had leaked electrolytes on the inside.There was no patient or operator impact.There was no surgical delay.Diligence is complete.
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).G2 foreign: canada.Evaluation and investigation is in process.Once the investigation is complete, a supplemental report will be filed.
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under.The following sections have been corrected/updated: b4, b5, d2, d4, g1, g3, g6, h1, h2, h3, h4, h6, h11.No product was returned; functional and/or dimensional evaluations could not be performed.Visual evaluation of the provided pictures found the device battery pack was deformed and the batteries leaked electrolyte within the battery pack.The battery terminals were pushed out of place.There did not appear to be any damage to the battery wiring.Dhr was reviewed and no discrepancies related to the reported event were found.The root cause of the reported issue is attributed to a manufacturing issue.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
No additional information is available.

• 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: 21864394
• Report Number: 0001526350-2025-00507
• Device Sequence Number: 20812523
• Product Code: FQH
• UDI-Device Identifier: 00889024375123
• UDI-Public: (01)00889024375123(17)270424(10)77048318
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2026

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 Catalogue Number: 00515042000
• Device Lot Number: 77048318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/23/2025
• Supplement Date Received by Manufacturer: 09/08/2025; 05/06/2026
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 09/09/2025; 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2024
• 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: Unknown