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

Model Number N/A

Device Problem Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 01/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Investigation summary: review of the device history record for 00515047500, lot number 63476127, identified no relevant deviations or anomalies.Product examination found that the wire at the base of the hand piece of the unit appeared to have been cut by scissors.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.¿ capa (b)(4) is in process to directly address customers cutting the battery cable.The root cause for this complaint is that the customer cut the wire, creating a short circuit within the battery pack.This short circuit caused the reported event.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 by the account that the grey cord from the battery was not connected to the hand piece during setup for surgery.Investigation results revealed that cutting the battery wire can cause combustion due to a short circuit.No adverse events were reported as a result of this malfunction.

• 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: 6831066
• MDR Text Key: 83997478
• Report Number: 0001526350-2017-00592
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 08/30/2017

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: 09/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 00515047500
• Device Lot Number: 63476127
• Other Device ID Number: (01)00889024375154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/28/2017
• Initial Date FDA Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• 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