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

Model Number N/A

Device Problems Battery Problem (2885); Expulsion (2933); Explosion (4006)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/18/2020

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).(b)(6).Once the investigation is complete, a follow up/final report will be submitted.

Event Description

It was reported that during the surgery, it was found that the batteries were exploded inside of the sterile tray before opened this complaint product.There was no harm or injury to the patient.There was a delay of 0-15 minutes to prepare an alternate product to complete the procedure.No adverse events were reported as a result of this malfunction.

Event Description

No additional event information available.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Visual examination of the returned product and provided pictures identified that the battery pack was busted open and debris and internal parts of the battery pack were found throughout the package.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Device is used for treatment.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.A definitive root cause cannot be determined.The event is confirmed.

• Brand Name: PULSAVC PLUS FAN SPRAY KIT INT
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 11146747
• MDR Text Key: 226011459
• Report Number: 0001526350-2021-00031
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 00889024375161
• UDI-Public: (01)00889024375161(17)230630(10)64750039
• 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: 03/09/2021

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: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 00515047501
• Device Lot Number: 64750039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/11/2021
• Supplement Dates Manufacturer Received: 03/03/2021
• Supplement Dates FDA Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1