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

Catalog Number 00515047501

Device Problems Fluid/Blood Leak (1250); Battery Problem (2885)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under cmp-(b)(4).The investigation is still in progress.Once the investigation is complete a follow up mdr will be submitted.

Event Description

It was reported that this product became not able to spray from the middle of the surgery and made abnormal noises.Some liquid leaked from the battery.There was no harm to the patient and there was a 0-15 minute delay to prepare an alternate product.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.Reported issue: it was reported that this product became not able to spray from the middle of the surgery and made abnormal noises.Some liquid leaked from the battery.There was no harm to the patient and there was a 0-15 minute delay to prepare an alternate product.No adverse events were reported as a result of this malfunction.Dhr review: the device history record (dhr) for 00515047501, could not be performed as a lot number was not provided for the reported event.Technical review and physical evaluation: on (b)(6) 2019, it was reported from the (b)(6) hospital that this product became not able to spray from the middle of the surgery and made abnormal noises.Some liquid leaked from the battery.There was no harm to the patient and there was a 0-15 minute delay to prepare an alternate product.No adverse events were reported as a result of this malfunction.On 10 february 2020, a returned product investigation was performed on the 00515047501.The physical evaluation revealed that the device had a warped motor mounts and evidence of corrosion in the battery pack.The results of the returned product investigation have confirmed the reported event.Probable cause/root cause: while the returned product investigation confirmed that the 00515047501 was no longer able to spray saline water due to warped motor mounts and battery corrosion, it cannot be determined from the information provided what actually caused the batteries to rupture or the motor mounts to warp.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 (ie/capa/scar/hhe/d).This complaint will be tracked and trended for any adverse trends that may warrant further action.

Event Description

No additional information.

• 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: 9520436
• MDR Text Key: 197314026
• Report Number: 0001526350-2019-01189
• 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: 02/24/2020

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 Catalogue Number: 00515047501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/26/2019
• Supplement Dates Manufacturer Received: 02/17/2020
• Supplement Dates FDA Received: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1