MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. FAN SPRAY KIT; PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FAN SPRAY KIT

Model Number N/A

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/30/2015

Event Type  malfunction  

Manufacturer Narrative

The device history record (dhr) review was not performed for any of the 5 returned devices.The production trace lot numbers were not reported and are unknown.The batteries list an expiration date of mar, 2016.Therefore, the batteries would have been delivered and placed into inventory at zimmer surgical in mar, 2010.Due to the severity of the corrosion the reported event is considered an out of the box event.Five units of the 00-5150-475-00 pulsavac plus were returned on 18 jun, 2015.All the devices were shipped loose inside a zip lock plastic bag.Visual inspection noted no obvious damage with the devices and the battery packs were not deformed.Visually the devices did display heavy wear and tear and dirt.Though this may have occurred in transit.Two of the devices were returned with the trigger depressed to engage the high speed mode and one device was returned with the trigger depressed in the low speed mode.All five devices did not function in the high speed or low speed mode when tested on 18 jun, 2015.Opening the battery packs it was discovered that all of the battery terminals and batteries had rust and corrosion.In two battery cases there was one battery that split open.In two battery cases there were two batteries that split open and in one battery case there were four batteries that had split open.Note, no anode expulsion was discovered.The corrosion on the terminals was extensive and could not be cleaned for retesting.All intact batteries in all of the devices were completely exhausted.The customers reported event that all five devices did not function.Additionally, it was reported that this same event had been experienced previously.Incoming inspection and functional test confirmed the customers reported event.The cause for the product failure is most likely due to the rust and corrosion on the battery terminal and probably caused the leakage from the batteries.The most likely cause for the battery corrosion is probably environmental conditions in storage or in transit.Recommended actions: with the initiation of the capa, no additional internal zimmer actions are warranted at this time.

Event Description

It was initially reported that the device did not function while using during surgery.The switch was turned on and off, still it did not work.There was no patient/user harm or surgical delay reported as a result of the reported issue.The surgery was completed with an alternate device.Additional clinical information determined that five devices were associated with the reported issue and failed to function during surgery on (b)(6) 2015.This issue is being reported as a malfunction due to the evidence of battery leakage observed during evaluation of the returned devices.

• Brand Name: FAN SPRAY KIT
• Type of Device: PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FAN SPRAY KIT
• 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: david bailey ; 200 west ohio avenue; dover, OH 44622 ; 3303438801
• MDR Report Key: 6065915
• MDR Text Key: 59030149
• Report Number: 0001526350-2016-00118
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/25/2015

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: 00515047500
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2015
• Initial Date FDA Received: 10/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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