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

Catalog Number	00515042000
Medical Device Problem Codes	Corroded (1131); Leak/Splash (1354); Explosion (4006)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pulsavac did not function, opened the battery pack to find corrosion on batteries.Per the image the fifth battery from the right leaked electrolyte.There was no patient involvement.There is no harm or delay reported.Due diligence is complete.
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).A follow up/ final report will be submitted once investigation is complete.
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).The following sections have been corrected/updated: b4, b5, d2, d4, g1, g3, g6, h1, h2, h4, h6, h11.No product was returned.The provided photos confirmed that the batteries were corroded.Dhr was reviewed and no discrepancies related to the reported event were found.The root cause of the reported issue is attributed to the 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.
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: 21619244
• Report Number: 0001526350-2025-00323
• Device Sequence Number: 6828397
• Product Code: FQH
• UDI-Device Identifier: 00889024375123
• UDI-Public: (01)00889024375123(17)270424(10)77048318
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

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: 77048318
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Supplement Date Received by Manufacturer: 08/16/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 42502607001 LOT 66713671; 42532007901 LOT 66892135; 42540000035 LOT 67037354
• Patient Sex: Unknown