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

Catalog Number 00-5150-475-00

Device Problems Material Separation (1562); Device Operates Differently Than Expected (2913)

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

Event Date 10/18/2013

Event Type  malfunction  

Event Description

It was reported that the head of the sprayer on the device disengaged causing fluids to be sprayed on the surgical team.Additional clinical follow up with the customer indicated that the irrigation fluid hit the surgeon's non-sterile face shield as well as his assistant's ppe; however there was no room staff direct skin contact made with the fluid exposure.The surgeon's concern was that "the fact that sterile fluid came in contact with his non-sterile face shield and landed in the pt's incision".

Manufacturer Narrative

The device was not returned to the manufacturer for evaluation.Although the device was not returned to the manufacturer, the cause of the complaint was contributed to the press fit tip locking mechanism on the pulsavac plus.A design change has been implemented to address this issue.

• 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: 3824009
• MDR Text Key: 4399780
• Report Number: 1526350-2014-00113
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 01/24/2014

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 Catalogue Number: 00-5150-475-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2014
• Initial Date FDA Received: 02/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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