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

Model Number N/A

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 09/27/2023

Event Type  malfunction  

Manufacturer Narrative

An investigation into the reported event has been initiated under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.G2: foreign: japan.

Event Description

It was reported that during surgery, a hair was found inside of the sterile tray when the nurse opened the sterile tray.There was no patient harm/injury.There was no medical intervention.There was a 0 -15 minute surgical delay for preparing an alternate device.Due diligence is complete, no further information is available.

Event Description

There is no additional information available.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The following sections have been corrected/updated: b4, b5, d2, d4, d9, g1, g3, g6, h1, h2, h3, h4, h6, and h10.The device was returned opened but unused.Visual inspection confirmed there was a long dark hair present inside the tyvek tray.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.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
• 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: 18061115
• MDR Text Key: 327264054
• Report Number: 0001526350-2023-01436
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 00889024375161
• UDI-Public: (01)00889024375161(17)251107(10)65709059
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/11/2024

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: 00515047501
• Device Lot Number: 65709059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2023
• Initial Date FDA Received: 11/02/2023
• Supplement Dates Manufacturer Received: 01/11/2024
• Supplement Dates FDA Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2022
• 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