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

Model Number N/A

Device Problems Burst Container or Vessel (1074); Expulsion (2933)

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

Event Date 04/20/2017

Event Type  malfunction  

Manufacturer Narrative

The udi number is (b)(4).The complaint is being reported by zimmer biomet as (b)(4).The product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during preparation for surgery, it was found that the product looked like it had 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

(b)(4).Initial medwatch was submitted erroneously.This is not reportable.

Manufacturer Narrative

This complaint is recorded with zimmer biomet under (b)(4).This medwatch is being filed as a initial although g7 states "follow-up" as it was earlier flipped for non-reportability per guidelines and has now been switched to being reportable to the fda.Review of the device history record for 00515047501, lot number z000005750, identified no relevant deviations or anomalies.Product examination found that the battery pack had ruptured from overheating 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.Change notice cn 22170 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.

Event Description

It was reported that during preparation for surgery, it was found that the product looked like it had 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.

• Brand Name: PULSAVAC PLUS FAN SPRAY KIT
• Type of Device: LAVAGE, JET
• 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: 6585458
• MDR Text Key: 75778323
• Report Number: 0001526350-2017-00297
• 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,Followup
• Report Date: 08/03/2017

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 Model Number: N/A
• Device Catalogue Number: 00515047501
• Device Lot Number: Z000005750
• Other Device ID Number: 00889024375161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/12/2017
• Initial Date FDA Received: 05/23/2017
• Supplement Dates Manufacturer Received: Not provided; 08/03/2017
• Supplement Dates FDA Received: 05/24/2017; 08/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1