MAUDE Adverse Event Report: ZIMMER SURGICAL FAN SPRAY KIT

Catalog Number 00-5150-475-01

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 04/01/2014

Event Type  malfunction  

Event Description

It was reported that the low mode was not available on this pulsavac plus fan spray kit.This surgery was finished with using another pulsavac plus.There was no pt harm or delay reported, and the procedure was completed with an alternate device.

Manufacturer Narrative

The device was returned to the mfr for repair and eval.The service record indicates that the device was manufactured and released into inventory on (b)(4) 2013.Eval of the device observed the unit would not function in low or high mode unless the trigger was pulled firmly.The trigger would make intermittent contact in the both modes.The gun was opened and found to have the trigger terminals slightly bent.There was also corrosion found through the inside of the gun and on two battery pack terminals.It is not known what caused this corrosion.The corrosion did not affect the functionality of the unit and is not related to the reported complaint condition.The cause of the reported issue is undetermined.

• Brand Name: FAN SPRAY KIT
• Type of Device: FAN SPRAY KIT
• Manufacturer (Section D): ZIMMER SURGICAL; 200 west ohio ave.; dover OH 44622
• Manufacturer Contact: kethleen smith ; 200 west ohio ave.; dover, OH 44622 ; 3303438801
• MDR Report Key: 3886624
• MDR Text Key: 18928219
• Report Number: 1526350-2014-00278
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 04/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00-5150-475-01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/27/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1