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

Model Number N/A

Device Problem Expulsion (2933)

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

Event Date 06/21/2017

Event Type  malfunction  

Manufacturer Narrative

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 the battery pack exploded when the nurse tried to discard the battery pack and cut its cable.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Investigation summary: review of the device history record for 00515047501, lot number: z000006716, identified no relevant deviations or anomalies.Product examination found that the battery pack had ruptured from a short circuit due to a cut wire.This complaint is confirmed.The reported event claimed that the battery wire of the unit was cut and later on the battery pack became hot and close to combustion.It is known that cutting the wire can create a short circuit within the battery pack.The pulsavac ifu states, ¿do not cut the battery pack cable.Cutting through the battery pack cable could lead to shock, excessive heat and/or sparks, and could result in fire and/or personal injury.¿ the root cause for the battery pack rupturing was due to the user cutting the wire, creating a short circuit within the battery pack.The reported event was confirmed during inspection of the device.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The following sections were updated/corrected.

• Brand Name: 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: 6688085
• MDR Text Key: 79120436
• Report Number: 0001526350-2017-00403
• 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: 12/11/2017

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: 01/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 00515047501
• Device Lot Number: Z000006716
• Other Device ID Number: (01)00889024375161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/21/2017
• Initial Date FDA Received: 07/05/2017
• Supplement Dates Manufacturer Received: 12/11/2017; 12/11/2017
• Supplement Dates FDA Received: 12/11/2017; 12/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2017
• 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