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

Catalog Number 00-5150-475-00

Device Problems Corroded (1131); Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 06/01/2014

Event Type  malfunction  

Event Description

It was reported that during surgery the zimmer pulsavac plus handgun failed to function.Additional follow-up determined that there was no patient involvement or patient injury associated with the report and an alternate device was retrieved for use during the surgery without delay.During device evaluation it was observed that there was corrosion present on three of the batteries and the corresponding contact plates.

Manufacturer Narrative

The customer's reported event was confirmed.The device did not operate upon receipt or when fresh batteries were installed.A root cause for this reported event cannot be determined.Processing the device, by the customer, through the autoclave prohibited isolating a single root cause.The device was returned in a plastic bag and there was no marking or identification on this bag.The only identification was on the product experience report and the outside of the shipping carton.Initial inspection observed that the unit did not function when engaging the trigger.Inspection of the battery pack displayed corrosion on three of the batteries and the corresponding contact plates.Additionally, the battery pack was assembled using uncoated brass terminals and everyready gold batteries.The everyready batteries listed an expiration date on 2012.The device did not operate upon receipt or when fresh batteries were installed.However, the reported lot number for this device is incorrect.The reported lot number was manufactured in 2013 with nickel coated battery terminals and energizer batteries with an expiration date of 2023.The returned device was assembled with uncoated brass battery terminals and everready gold batteries, expiration date of 2012.The engineering change to add nickel plating to the brass terminals to reduce corrosion was issued in 2008.The returned device could not have been manufactured after 2009 and therefore cannot be from the reported lot #62510132.The lot # of the returned device was unable to be determined.

• Brand Name: PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FAN
• Type of Device: PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FAN
• 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: 4139679
• MDR Text Key: 4917002
• Report Number: 1526350-2014-00436
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 09/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00-5150-475-00
• Device Lot Number: 62510132
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/25/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2014
• 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
• Patient Sequence Number: 1