MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. FAN SPRAY KIT; DISPOSABLE BATTERY-POWERED SURGICAL/ORTHOPAEDIC LAVAGE SYSTEM

Catalog Number 00515047500

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Code Available (3191)

Event Date 11/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Once the investigation is complete, a follow up/final report will be submitted.(b)(4).

Event Description

During the surgery there was an incident related to the pulsavac system.While performing rinsing with the system, the part where the batteries are located began to heat up rapidly and hiss.When one of the staff nurse removed it from the hanger, the liquid leaked (from unsealed batteries), it was poured over staff nurse, but she wiped if off her and there was no visible damage to the body.This part was cut off and put aside for cooling.No additional adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This follow up report is being submitted to report additional information.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 battery pack that ruptured, however it cannot be determined from the information provided what caused the battery pack to rupture.These photos confirm the reported event.The root cause of the reported event cannot be specifically determined with the provided information because the product was not returned for evaluation.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Event Description

Pictures of the device received.

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.The device history record (dhr) for (b)(4), could not be performed as a lot number was not provided for the reported event.On (b)(6) 2018, it was reported from ortopedyczno-rehabilitation that while performing rinsing with the system, the part where the batteries are located began to heat up rapidly and hiss.A returned product investigation could not be performed for the reported event due to the product not being returned for evaluation.The reported event can, therefore, not be confirmed.The root cause of the reported event cannot be specifically determined with the provided information because the product was not returned for evaluation.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Manufacturer Narrative

(b)(4).

Event Description

While performing rinsing with the system, the part where the batteries are located began to heat up rapidly and hiss.When one of the staff nurse removed it from the hanger, the liquid leaked (from unsealed batteries), it was poured over staff nurse, but she wiped if off her and there was no visible damage to the body.This part was cut off and put aside for cooling.The event occurred during cleaning (after surgery), hence there was no delay, and no alternate product was required.No additional adverse events were reported as a result of this malfunction.

Event Description

No additional information received.

Manufacturer Narrative

This follow up is being submitted to report additional information.On 29 november 2018, it was reported from ortopedyczno-rehabilitacyjny that while performing rinsing with the system, the part where the batteries are located began to heat up rapidly and hiss.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 battery pack that ruptured, however it cannot be determined from the information provided what caused the battery pack to rupture.These photos confirm the reported event.Although the reported event was confirmed with pictures from the account, it cannot be determined from the information 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.

• Brand Name: FAN SPRAY KIT
• Type of Device: DISPOSABLE BATTERY-POWERED SURGICAL/ORTHOPAEDIC LAVAGE SYSTEM
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8196780
• MDR Text Key: 131414147
• Report Number: 0001526350-2018-01129
• 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,Followup,Followup,Followup
• Report Date: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00515047500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/26/2018
• Supplement Dates Manufacturer Received: 02/01/2019; 03/04/2019; 04/26/2019; 04/29/2019
• Supplement Dates FDA Received: 02/04/2019; 03/06/2019; 04/29/2019; 04/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1