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

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2020

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Visual inspection of the returned product found that one of the batteries in the battery pack had leaked and crystalized inside the pack.Functional testing confirmed the device would not power on when connected to the battery pack returned with the device.After removing the faulty battery and replacing it with a new battery, the pulsavac powered on and functioned normally device is used for treatment.A definitive root cause cannot be determined.The event is confirmed.

Event Description

It was reported that the pulsa vac didn't work properly.The surgeon used another product.No, further information on what happened with the device/ lot number 64750040 / the incident occurred before the start of use.0-15 minute delay to the surgery to obtain alternate device.No harm / injury to the patient or operator.Investigation showed the battery pack had leaked and crystalized.No adverse event was reported as a result of this malfunction.

• Brand Name: FAN SPRAY KIT
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 11732246
• MDR Text Key: 247552337
• Report Number: 0001526350-2021-00487
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 00889024375161
• UDI-Public: (01)00889024375161(17)230630(10)64750040
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/27/2021

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: 64750040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2021
• Initial Date FDA Received: 04/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1