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

Catalog Number 00515047500

Device Problems Fluid/Blood Leak (1250); Expulsion (2933)

Patient Problem Injury (2348)

Event Date 12/18/2018

Event Type  Injury  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The investigation is still in progress.One the investigation is complete a follow up mdr will be submitted.

Event Description

It was reported that the battery pack was separated from the irrigation system by cutting of the wires.The battery pack was left in the or theater on top of the coagulation machine for a couple of hours.The or staff noticed that the battery pack was starting to make a popping and hissing sound.In the process of removing the battery pack from the theater by one of the nurses, the device started emitting a fine spray on the arms of the nurse.The device was brought to the soiled holding area where upon it exploded sending a liquid onto the floor and into the eyes of the housekeeping.This required washing and irrigation of the employees eyes.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Udi# (b)(4).The device history record (dhr) for 00515047500 lot number 64009072, review noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.On 18 december 2018, it was reported from brockville general that the battery was cut from the device and ruptured.On 20 march 2019, a returned product investigation was performed on the 00515047500.The physical evaluation revealed that the battery pack had been cut from the device and had ruptured.The results of the returned product investigation have confirmed the reported event.The returned product investigation confirmed that the fan spray kit battery had ruptured due to a cut battery pack cable.The zimmer biomet pulsavac plus would debridement system instruction for use (ifu) states on page one to not cut the battery pack cable.An ifu is shipped to the customer with each purchased pulsavac system.

Event Description

The employee who required intervention "is fine and has returned to work".

• Brand Name: FAN SPRAY KIT
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8236633
• MDR Text Key: 132779477
• Report Number: 0001526350-2019-00012
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 00515047500
• Device Lot Number: 64009072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other