MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. FAN SPRAY KIT; DISPOSABLE SURGICAL IRRIGATION/ASPIRATION SYSTEM

Model Number	N/A
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).Evaluation and investigation are in process.Once the investigation is complete, a supplemental report will be filed.
Event or Problem Description
It was reported that prior to surgery the staff noticed plastic debris in packaging.There was no patient involved and no harm, impact, or delay reported.Another device was available to complete the surgery.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.No product was returned; functional, visual, and/or dimensional evaluations could not be performed.Visual evaluation of the provided pictures found one reddish particulate within the sterile packaging.It could not be determined if the particulate was loose or embedded, or if the packaging seal was opened; unable to confirm reported event.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.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.
Event or Problem Description
No additional event information available.

• Brand Name: FAN SPRAY KIT
• Common Device Name: DISPOSABLE SURGICAL IRRIGATION/ASPIRATION SYSTEM
• 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: 18135111
• Report Number: 0001526350-2023-01506
• Device Sequence Number: 6349364
• Product Code: FQH
• UDI-Device Identifier: 00889024375178
• UDI-Public: (01)00889024375178(17)260530(10)70849533
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/10/2024

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 Expiration Date: 05/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 00515047601
• Device Lot Number: 70649533
• 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: 10/19/2023
• Supplement Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose