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

Catalog Number 00515047501

Device Problem Expulsion (2933)

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

Event Date 07/10/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Once the investigation is completed, a follow-up/final report will be submitted.

Event Description

It was reported that during the surgery, this product didn't work on low mode unless the surgeon keeps gripping the switch and it also stopped working on high mode in a short time.In photos included with the event, one of the batteries expelled acid.No adverse events were reported as a result of this malfunction.

Event Description

There was no harm reported, and a delay of 0-15 minutes reported to obtain an alternate device to complete the surgery.No additional event information available.

Manufacturer Narrative

D4: udi# (b)(4).Reported issue: it was reported that during the surgery, this product didn't work as usual.This product didn't work on low mode unless the surgeon keep gripping the switch.And this product stopped working on high mode in a short time.The device history record (dhr) for 00515047501 lot number 64245213, review noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.Technical review and physical evaluation: on (b)(6) 2019, it was reported from (b)(6) hospital that during the surgery, this product didn't work as usual.This product didn't work on low mode unless the surgeon keep gripping the switch.And this product stopped working on high mode in a short time.On 12 august 2019, a returned product investigation was performed on the 00515047501.The physical evaluation revealed that the device was not working as intended, and further review noted corrosion in the battery pack.When the corroded battery was replaced, the device functioned as intended.The results of the returned product investigation have confirmed the reported event.While the returned product investigation confirmed that the 00515047501 was not functioning as intended due to a corroded battery, it cannot be determined from the information provided what actually caused the reported event.Therefore, based on the information provided, a specific root cause of the reported event cannot be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Review of the information provided during the investigation determined there is no further actions needed at this time.

• 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: 8797959
• MDR Text Key: 151301121
• Report Number: 0001526350-2019-00557
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 08/14/2019

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: 12/31/2021
• Device Catalogue Number: 00515047501
• Device Lot Number: 64245213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2019
• Initial Date FDA Received: 07/17/2019
• Supplement Dates Manufacturer Received: 08/14/2019
• Supplement Dates FDA Received: 08/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1