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

Model Number N/A

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2023

Event Type  malfunction  

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 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.

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 Description

No additional event information available.

• Brand Name: FAN SPRAY KIT
• Type of Device: 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
• MDR Text Key: 328086288
• Report Number: 0001526350-2023-01506
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 00889024375178
• UDI-Public: (01)00889024375178(17)260530(10)70849533
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 10/19/2023
• Initial Date FDA Received: 11/14/2023
• Supplement Dates Manufacturer Received: 04/10/2024
• Supplement Dates FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose