MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS PULSAVAC PLUS FAN SPRAY KIT

Catalog Number 00-5150-475-01

Device Problems Device Operates Differently Than Expected (2913); Noise, Audible (3273)

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

Event Date 06/01/2014

Event Type  malfunction  

Event Description

It was reported that the zimmer pulsavac plus had stopped while in use.In operation, noise had occurred.The customer used and finished the surgery with an alternate one.

Manufacturer Narrative

The device was not returned in the original zimmer carton, but in a clear plastic bag.Upon receipt it was noted that the device was received with the trigger locked in the low mode.The device did not operate at all.The device was opened up and corrosion on the terminal and on one of the batteries was discovered.All the batteries were completely depleted.Scrapping the corrosion off the terminal and replacing all the batteries allowed the device to operate normally.No noise issue was observed; however the customer's reported event of the device not working was confirmed.The root cause of the device not working is unable to be determined.When the corrosion occurred on the battery and when the depletion of the batteries occurred is unknown.The condition of the original shipping package at receipt and the storage environment of the device, at the customer as well as the length of time in storage are unknown.A review of the zimmer surgical manufacturing, packing and inspection processes denotes no issues indicative to this type of failure.The cause for the battery degradation is unknown.

• Brand Name: PULSAVAC PLUS FAN SPRAY KIT
• Type of Device: PULSAVAC PLUS FAN SPRAY KIT
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS; 200 west ohio ave.; dover OH 44622
• Manufacturer Contact: kathleen smith ; 200 west ohio ave.; dover, OH 44622 ; 3303438801
• MDR Report Key: 4173562
• MDR Text Key: 17260969
• Report Number: 1526350-2014-00409
• 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: Other
• Type of Report: Initial
• Report Date: 08/01/2014

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: 00-5150-475-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/23/2014
• Initial Date FDA Received: 08/07/2014
• 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