MAUDE Adverse Event Report: Zimmer Surgical, Inc. FAN SPRAY KIT; lavage, jet

Catalog Number	00515047500
Medical Device Problem Codes	Failure to Power Up (1476); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction

• 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: 50439132
• Report Number: 0001526350-2026-01035
• Device Sequence Number: 15756476
• Product Code: FQH
• UDI-Device Identifier: 00889024375154
• UDI-Public: (01)00889024375154(17)280525(10)83243886
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2026

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
• Device Catalogue Number: 00515047500
• Device Lot Number: 83243886
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/18/2025
• 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: 08/25/2026
• Initial Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2025
• 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 Age: 61 YR
• Patient Sex: Male