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 10/19/2017

Event Type  malfunction  

Manufacturer Narrative

This complaint is recorded with 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. .

Event Description

It was reported that during the surgery, the product looked like it had been exploded inside of the sterile package when the nurse opened it.Therefore, the nurse prepared an alternative one for the surgery.No adverse events have been reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Review of the device history record for 00515047501, lot number z000006903, identified no relevant deviations or anomalies.Product examination found that the battery pack had ruptured.The sterile packaging was still sealed.This complaint is confirmed.The root cause of the reported event is a short circuit of the unit.However, the source of this short circuit could not be determined due to the extent of the damage of this unit.Hhed 09-2017-001, which includes cn 22170, was created to address the length of the wires inside the battery pack in order to eliminate the need to fold them, reducing the likelihood of a short circuit.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

• Brand Name: FAN SPRAY KIT
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 7042182
• MDR Text Key: 93220444
• Report Number: 0001526350-2017-00865
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/28/2018

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: Z000006903
• Other Device ID Number: (01)00889024375161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Initial Date Manufacturer Received: 10/30/2017
• Initial Date FDA Received: 11/17/2017
• Supplement Dates Manufacturer Received: 03/27/2018
• Supplement Dates FDA Received: 03/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1