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

Catalog Number 00515047500

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 08/19/2023

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).G2 foreign: (b)(6).Evaluation and investigation is in process.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that at unknown timing on (b)(6), 2023 a hair-like foreign substance was found inside the sterilization tray but not on the device itself.There was no harm, injury or delay reported.Due diligence is complete; no additional information.No adverse events were reported as a result of this malfunction.

Event Description

No additional information is available regarding the incident.

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).The product was returned opened, but unused, in the original tyvek tray.Visual inspection confirmed there was a long, hair-like debris on the product tubing.It cannot be confirmed if the device was non-conforming as the packaging was returned open.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.

• Brand Name: FAN SPRAY KIT
• Type of Device: 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: 17806681
• MDR Text Key: 324114378
• Report Number: 0001526350-2023-01193
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 00889024375154
• UDI-Public: (01)00889024375154(17)240524(10)65123209
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/15/2023

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 Expiration Date: 05/24/2024
• Device Catalogue Number: 00515047500
• Device Lot Number: 65123209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/29/2023
• Initial Date FDA Received: 09/25/2023
• Supplement Dates Manufacturer Received: 12/14/2023
• Supplement Dates FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2021
• 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