MAUDE Adverse Event Report: ZIMMER SURGICAL PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FAN

Catalog Number 00-5150-475-00

Device Problems Corroded (1131); Leak/Splash (1354); Device Inoperable (1663)

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

Event Date 02/13/2015

Event Type  malfunction  

Event Description

It was reported that the pulsavac did not function while using.The switch was turned on and off, still it did not work.There was no patient harm or surgical delay reported.An alternate device was retrieved to complete the surgical procedure without delay.This event is being reported based on the results of the device evaluation indicating that there was leakage and corrosion of the batteries and battery pack.

Manufacturer Narrative

The customer's reported event was confirmed.The device did not operate upon receipt.Visually the device displayed no obvious defects and the battery terminal appeared to be unharmed.The device did not function in high or low speed mode when the trigger was manipulated.The battery pack was opened and discovered the batteries had corroded.No anode ejection was visible; however, a galvanic reaction occurred as evidence by the green and white trace (mold) on the battery terminals.The probable cause for the device failure is the corrosion of the batteries and battery pack.The most likely cause for the corrosion is due to battery leakage from environmental conditions in storage.The true root cause of the battery corrosion is unknown.A review of the zimmer surgical manufacturing, packing and inspection processes denotes no systemic issues indicative to this type of failure.The review of the device history record noted no issues with the assembly of this production lot of parts.There were no internal zimmer non-conformances for the battery lot initiated at incoming inspection or from the manufacturing area.In addition, each pulsavac device is functionally tested multiple times at assembly.Storage of batteries in hot and humid conditions over time can cause the battery to vent as gases build up inside the cell.Additionally, a failure of a single battery may cause some or all of the remaining batteries to discharge due to a short in the power circuit.

• Brand Name: PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FAN
• Type of Device: PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM
• Manufacturer (Section D): ZIMMER SURGICAL; 200 west ohio ave.; dover OH 44622
• Manufacturer Contact: kathleen smith ; 200 west ohio ave.; dover, OH 44622 ; 3303438801
• MDR Report Key: 4808484
• MDR Text Key: 5894625
• Report Number: 1526350-2015-00097
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/26/2015

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 Expiration Date: 02/13/2017
• Device Catalogue Number: 00-5150-475-00
• Device Lot Number: 62610396
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/23/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2015
• Initial Date FDA Received: 05/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1