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

Model Number N/A

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Battery Problem (2885); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/20/2016

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to the manufacturer at the time of this report.A follow up medwatch will be submitted once the device has been returned and the investigation is complete.

Event Description

It was initially reported that during surgery, the product did not work.The surgeon opened an alternative device to complete the surgery.Additional information stated that after the complaint was received, the product was dismantled it for investigation; it was confirmed that some liquid leaked from the battery.Additional information received on (b)(6) 2016 stated that the event occurred during surgery on (b)(6) 2016.There was no harm, injury or adverse event to the patient or operator.There was no additional medical intervention or additional surgical procedure required.There was a slight delay/extension in the surgery (0-15 minutes) to allow for the exchange of product.There were no contributing conditions related to the event and the proper surgical technique for the product was utilized.

Manufacturer Narrative

The complaint is being reported by zimmer biomet as (b)(4).This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Review of the device history record for 00515047501, lot number 63433091, identified no deviations or anomalies.Product examination found that the unit would not function at all.Inside the battery pack, one of the batteries had leaked and corroded the adjacent battery contacts.This complaint is confirmed.There is a small possibility of failure within the individual batteries in the battery pack.However, without knowing more about the reported event, the root cause cannot be specifically determined with the provided information.

• 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: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6260165
• MDR Text Key: 65567072
• Report Number: 0001526350-2017-00018
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 00515047501
• Device Lot Number: 63433091
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2016
• 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