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

Catalog Number 00515047501

Device Problem Expulsion (2933)

Patient Problem No Patient Involvement (2645)

Event Date 03/07/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The device history record (dhr) for 00515047501, could not be performed as a lot number was not provided for the reported event.On (b)(6) 2019, it was reported from (b)(6) hospital that battery pack had ruptured after they had cut the battery pack cable.On 29 march 2019, a returned product investigation was performed on the 00515047501.The physical evaluation revealed that the device battery pack had ruptured and the battery pack cable was cut.The results of the returned product investigation have confirmed the reported event.The returned product investigation confirmed that the fan spray kit battery had ruptured due to a cut battery pack cable.The zimmer biomet pulsavac plus would debridement system instruction for use (ifu) states on page one to not cut the battery pack cable.An ifu is shipped to the customer with each purchased pulsavac system.Therefore, based on the information provided, the root cause of the battery pack rupturing was due to a cut battery pack cable.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Event Description

It was reported that the battery pack was exploded when the customer tried to discarded it.And the cable which leads to the battery pack had been already cut when we received it.No adverse events were reported as a result of this malfunction.

• Brand Name: PULS PLUS 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: 8482525
• MDR Text Key: 140900677
• Report Number: 0001526350-2019-00217
• Device Sequence Number: 1
• Product Code: FQH
• 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: 04/04/2019

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 Catalogue Number: 00515047501
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/07/2019
• Initial Date FDA Received: 04/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1