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

Model Number N/A

Device Problem Expulsion (2933)

Patient Problem No Patient Involvement (2645)

Event Date 05/13/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Once the investigation is complete, a supplemental/final medwatch will be filed.Hospital discarded.

Event Description

It was reported that the pulsavac plus of wound debridement exploded upon opening from the package.No harm.No delay.No adverse events were reported as a result of this malfunction.

Event Description

No additional information available.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Unique identifier (udi) number: (b)(4).Dhr review: the device history record (dhr) for 00515047500 lot number 64215408, 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 east (b)(6) center that the pulsavac plus of wound debridement exploded upon opening from the package.A returned product investigation could not be performed for the reported event due to the product not being returned for evaluation.Photos of the device were provided by the account, however.The photos indicate that the a device had a ruptured battery.These photos confirm the reported event.Probable cause/root cause: although the reported event was confirmed with photos supplied by the account, it cannot be specifically determined from the information provided what caused the batteries to rupture.Therefore, the root cause could not 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.The occurrence rate falls within the acceptable range, and there was no harm or serious injury.This complaint will be tracked and trended.

• 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: 8658723
• MDR Text Key: 147068074
• Report Number: 0001526350-2019-00408
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 08/20/2019

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: 11/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 00515047500
• Device Lot Number: 64215408
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/13/2019
• Initial Date FDA Received: 05/31/2019
• Supplement Dates Manufacturer Received: 08/20/2019
• Supplement Dates FDA Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1