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

Catalog Number	00515047500
Medical Device Problem Codes	Battery Problem (2885); Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event is recorded with zimmer biomet under (b)(4).This medwatch is being filed as an initial / final report based on information discovered during the device evaluation.Only the battery pack was returned for evaluation; therefore, functional testing could not be performed.Visual examination of the returned product/provided pictures found the outer pack was warped and the interior had electrolyte leaked inside the pack.There did not appear to be any damage to the wiring.Review of the device history record identified no deviations or anomalies during manufacturing.The root cause of the reported issue is attributed to a design and/or 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.G2: foreign - event occurred in germany.
Event or Problem Description
It was reported that during surgery, the battery is defective, so it cannot be used.There was no patient harm.There was a 1-minute delay as a new product had to be retrieved from storage and connected.There was no medical intervention.The battery did not exhibit expulsion, leaking electrolyte/acid, explodes, or ruptures.They used the product as usual ¿ with a continuous trigger operation as always.When they used the same product afterwards the same way, there were no problems with it.The pulsavac wasn¿t even working, it never started.During device evaluation and visual examination, it was discovered that the interior had electrolyte leaked inside the pack.Due diligence is complete, there is no additional information available.

• 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: 24944946
• Report Number: 0001526350-2026-00481
• Device Sequence Number: 5241903
• Product Code: FQH
• UDI-Device Identifier: 00889024375154
• UDI-Public: (01)00889024375154(17)280331(10)82087526
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 04/21/2026

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: 00515047500
• Device Lot Number: 82087526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2025
• 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: 04/20/2026
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2025
• 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