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

Catalog Number	00515047501
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the device did not work.There was no patient injury, or delay.After investigation visual inspection found that batteries had leaked electrolyte inside of the pack.Due diligence is complete and there is no additional information available.
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).G2: foreign - event occurred in japan complaint can be confirmed through the returned product analysis.Visual examination of the returned product identified functional testing found the device would not power on with the original battery pack but did power on and function normally in both modes 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.The device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause has been identified as device manufacturing process.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.

• Brand Name: FAN SPRAY 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: 24746319
• Report Number: 0001526350-2026-00373
• Device Sequence Number: 8780494
• Product Code: FQH
• UDI-Device Identifier: 00889024375161
• UDI-Public: (01)00889024375161(17)271001(10)79428560
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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: 00515047501
• Device Lot Number: 79428560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2025
• 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: 03/24/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2024
• 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