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

Model Number N/A

Device Problem Battery Problem (2885)

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

Event Date 11/12/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during the surgery, this product didn't work on high from the start of use.Upon receipt of the device and evaluation it was found that there was battery deposits or leakage.No adverse events were 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.The following sections were updated/corrected: b4, b5, d10, g4, g7, h2, h3, h6, h10.Reported issue: it was reported that during the surgery, this product didn't work on high from the start of use.Upon receipt of the device and evaluation it was found that there was battery deposits or leakage.Dhr and repair history review: this investigation is being completed as a limited investigation as no problem was found with the device.Therefore the complaint history and dhr reviews are not required.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 on high from the start of use.On 13 november 2019, a returned product investigation was performed on the 00515047501.The physical evaluation revealed that the device functions as intended and there were no problems with the device.The results of the returned product investigation have not confirmed the reported event.Probable cause/root cause: the reported event was never confirmed during inspection of the device, and no problems were found with the unit.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.Conclusion: review of the information provided during the investigation determined there is no further actions needed at this time.This complaint will be tracked and trended for any adverse trends that may warrant further action.

Event Description

No additional event information available.

• 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: 9432238
• MDR Text Key: 191537072
• Report Number: 0001526350-2019-01126
• 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: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00515047501
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 01/16/2020
• Supplement Dates FDA Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1