MAUDE Adverse Event Report: Zimmer Surgical, Inc. FAN SPRAY KIT; Lavage, Jet

Catalog Number	00515047500
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the device did not spray and made an abnormal noise battery expulsion was confirmed after final investigation was completed.There was no patient impact and a delay of unknown time occurred while looking for a second pulsavac to wash the operation site.Due diligence is complete as no additional information is available.
Additional Manufacturer Narrative
(b)(4) g2: foreign - event occurred in singapore.Visual examination of the returned product/provided pictures identified electrolyte leakage within the battery pack; batteries were installed in the correct orientation; wiring was intact; no other damage was observed.Review of the device history record identified no deviations or anomalies during manufacturing.The root cause is attributed to a manufacturing issue exacerbated by a design 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.

• 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 ; +1(574)526-0384
• MDR Report Key: 50486482
• Report Number: 0001526350-2026-01053
• Device Sequence Number: 16003205
• Product Code: FQH
• UDI-Device Identifier: 00889024375154
• UDI-Public: (01)00889024375154(17)280616(10)83347330
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 08/27/2026

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: 83347330
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/15/2026
• 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: 08/27/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown