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

Model Number N/A

Device Problem Sparking (2595)

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

Event Date 12/05/2016

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Investigation summary: review of the device history record could not be performed as there was no lot number reported for this complaint.Product examination found that the battery pack had ruptured due to a short circuit.However, the returned product included only the battery pack, which had been separated from the hand unit by cutting the wire.Cutting the wire can directly result in the kind of damage both exhibited in the product examination and reported by the customer.The timing of this rupture cannot be determined and this reported event cannot be confirmed.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 surgery a spark came from the battery pack.Subsequently, the nurse opened an alternative one to complete the surgery.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: 6813202
• MDR Text Key: 83489724
• Report Number: 0001526350-2017-00566
• 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
• Report Date: 08/23/2017

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 Model Number: N/A
• Device Catalogue Number: 00515047501
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/21/2017
• Initial Date FDA Received: 08/23/2017
• 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: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1