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

Model Number N/A

Device Problems Overheating of Device (1437); Battery Problem (2885); Temperature Problem (3022)

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

Event Date 09/17/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was initially reported that the pulsavac was used without incident during the case.After the case, the nurse noticed the battery pack was very hot.Upon further inspection, it was that the batteries were deformed, presumably from getting hot.Additional information received on september 30, 2016 stated that the event occurred after a surgical procedure on (b)(6) 2016.There was no harm, injury or adverse event to the patient or operator, no extension/delay before or during surgery and no medical intervention or additional surgical procedure was required.

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.Additional information\evaluation: review of the device history record for (b)(4), lot number 63394452, identified no deviations or anomalies.Product examination found that the battery pack had melted from a short circuit due to a cut wire.This complaint is confirmed.The reported event claimed that the battery wire of the unit was cut and later on the battery pack became hot.It is known that cutting the wire can create a short circuit within the battery pack.The pulsavac ifu states, ¿do not cut the battery pack cable.Cutting through the battery pack cable could lead to shock, excessive heat and/or sparks, and could result in fire and/or personal injury.¿ the root cause for this complaint is that the customer cut the wire, creating a short circuit within the battery pack.This short circuit caused the reported event.

• 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: 6037887
• MDR Text Key: 57866949
• Report Number: 0001526350-2016-00111
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 00515047500
• Device Lot Number: 63394452
• Other Device ID Number: 00889024375154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1