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

Catalog Number	00515042000
Medical Device Problem Code	Explosion (4006)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that at unknown timing on january 27, 2025 the packaged pulsavac battery had exploded inside the packaging.Harm or delay is unknown.Diligence is in process.No additional information has been received.
Event or Problem Description
It was reported that prior to surgery while opening the delivery boxes, the pulsavac battery had exploded inside the packaging.There was no patient involvement.Diligence is complete, there is no additional information available.
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).The following sections have been corrected/updated: a1, b4, b5, d1, d2, d4, e3, g1, g3, g4, g6, h1, h2, h6, and h11.Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.
Event or Problem Description
No additional information is available.
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).The following sections have been corrected/updated: b4, b5, d2, g1, g3, g6, h1, h2, h4, h6, h11.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Dhr was reviewed and no discrepancies related to the reported event were found.The root cause of the reported issue is attributed to the manufacturing process.The event cannot be 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: 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: 22120013
• Report Number: 0001526350-2025-00701
• Device Sequence Number: 19861024
• 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): 10/06/2025

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
• 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: 05/06/2025
• Supplement Date Received by Manufacturer: 05/30/2025; 09/24/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 06/27/2025; 10/06/2025
• 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
• Patient Sex: Unknown