MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. PULSAVAC PLUS FAN SPRAY KIT

Catalog Number 00515047501

Device Problem Expulsion (2933)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This event was reported by zimmer biomet under (b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Received; however not yet evaluated.

Event Description

It was reported that during preparation for surgery, it was found that the product looked like exploded inside of the sterile package when the dealer opened the product's outer box.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This event was reported by zimmer biomet under (b)(4).Review of the device history record for 00515047501, lot number z000005550, identified no relevant deviations or anomalies.Product examination found that the battery pack had ruptured batteries.The sealed packaging had not been opened.This complaint is confirmed.The reported event claimed that the sealed unit had ruptured before it had been opened.While rare, this kind of event occurs when the batteries overheat from a short circuit.To address this issue, a change has been implemented to adjust the length of the wires inside the battery pack.This means that there will no longer be a need to tightly fold wires inside the battery pack in order for them to reach their respective circuit contacts.This reduces the risk of a short circuit.The root cause of the reported event could not be specifically determined with the provided information.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

• Brand Name: PULSAVAC PLUS FAN SPRAY KIT
• Type of Device: FAN SPRAY KIT
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6618506
• MDR Text Key: 76862828
• Report Number: 0001526350-2017-00345
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/04/2017

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: 10/31/2019
• Device Catalogue Number: 00515047501
• Device Lot Number: Z000005550
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/09/2017
• Initial Date FDA Received: 06/07/2017
• Supplement Dates Manufacturer Received: 08/02/2017
• Supplement Dates FDA Received: 08/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1