MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. FAN SPRAY KIT; PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FAN SPRAY KIT

Model Number N/A

Device Problems Burst Container or Vessel (1074); Temperature Problem (3022)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/30/2016

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to the manufacturer at the time of this report.A follow up medwatch will be submitted once the device has been returned and the investigation is complete.

Event Description

It was reported that upon completion of the surgical procedure, staff were cleaning equipment for transport to the css (center for specialized surgery).Staff cut the wire of the pulsavac plus wound debridement system and placed it on the mayo stand.Approximately 15 minutes later, the battery exploded.The battery pack was hot and black powder and ash was distributed in the room.Additional information received stated that the event timing was after the completion of surgery, so the surgery time was not extended, there was no harm, injury or adverse event to the patient or operator, the life/health of the patient was not at risk and medical intervention/additional surgical procedure was not required.

Manufacturer Narrative

The production trace lot is unknown so device history record review was not possible.The device was not returned for evaluation.No product was returned for testing.The review of the design and manufacturing processes noted no systemic issues relevant to this complaint.The customers reported event was that the healthcare provider cut the battery cord after surgery and the battery pack exploded and the batteries leaked.With just the available information we cannot with 100% certainty confirm the event or identify a true root cause.The instructions for use lists several situations that can cause a major electrical short in the battery pack.Historically though, the most prevalent cause for the battery pack exploding is due to severing the electrical wire from the battery pack to the hand-piece.Cutting the wire with the batteries still in place can cause catastrophic electrical short initiating anode expulsions of the batteries.The device instructions for use and the labeling on the tyvek lid warn that cutting the battery pack cable could lead to shock, excessive heat and/or sparks, and could result in fire or personal injury.The batteries should be physically removed from the battery pack, care should be taken and personal safety equipment should be worn.The instructions for use explicitly states: warnings: explosion hazard.Do not use in presence of flammable anesthetics or gases.Do not submerge handle in liquid as this may compromise the efficiency of the pump or alter the ph of the liquid.Do not cut the battery pack cable.Cutting through the battery pack cable could lead to shock, excessive heat and/or sparks, and could result in fire and/or personal injury.Do not submerge the battery pack in liquid.Additionally, the tyvek lid for the individual pulsavacs devices states: warning: explosion hazard.Do not use in presence of flammable anesthetics or gases.Do not submerge in liquid as this may compromise the efficiency of the pump or alter the ph of the liquid.Do not cut the battery pack cable.Cutting through the battery pack cable could lead to shock, excessive heat and/or sparks, and could result in fire and/or personal injury.Do no submerge the battery pack in liquid.Use caution when removing batteries.The battery pack contains alkaline batteries.Exposure to the contents of an open or leaking battery or their combustion products could be harmful.Avoid skin and eye contact.Use neoprene or natural rubber gloves and safety glasses with side shields when handling batteries.The customer reported that the battery pack had been severed from the device after the procedure.Speculatively, the most likely cause for this incident is improper disposal of the device in contradiction of the ifu warnings by the customer.The customer¿s personnel should have refresher training on the ifu for this product.The electrical wires of this device should never be cut or pulled out without the batteries being removed first.

Manufacturer Narrative

A device history record (dhr) review could not be performed.The production trace lot was not reported and is unknown.According to fed ex tracking shipping information a battery pack for the 00-5150-475-00 pulsavac plus was returned to zimmer biomet on may 18, 2016.The incoming package contained minimal information and traceability to a specific complaint was not readily apparent.The due diligence for product retrieval on this complaint was closed on may 17, 2016 due to lack of customer response.Due to inconsistencies in the receiving documentation and the complaint reported information a clear lineage between the returned product and this complaint was unable to be determined.On august 11, 2016 the returned pulsavac battery pack received on may 18, 2016 was found to be associated with this complaint.The initial product investigation and regulatory submission to date was performed based on not evaluating the product; therefore this complaint investigation was updated to reflect the findings associated with the returned battery pack.It should be noted that the only the battery pack was returned for evaluation; therefore the complete device was not available for evaluation.Incoming inspection on the returned battery pack was performed on august 24, 2016.Visual inspection of the battery packed noted that the grey electrical cable had been severed and the batteries had a catastrophic electrical short resulting in the expulsion of several anodes.The customers reported event was that after surgery, the electrical cable from the battery pack was cut away and the battery pack was placed on a mayo stand.Approximately, 15 minutes later the battery pack ¿exploded¿.The information provided and the condition of the battery pack confirms the customers reported event.The instructions for use list several situations that can cause a major electrical short in the battery pack.Historically though, the most prevalent cause for the battery pack exploding is due to severing the electrical wire from the battery pack to the hand-piece.Cutting the wire with the batteries still in place can cause catastrophic electrical short initiating anode expulsions of the batteries.The most likely cause for this incident is improper disposal of the device in contradiction of the ifu warnings by the customer.The device instructions for use and the labeling on the tyvek lid warn that cutting the battery pack cable could lead to shock, excessive heat and/or sparks, and could result in fire or personal injury.The batteries should be physically removed from the battery pack, care should be taken and personal safety equipment should be worn.The instructions for use explicitly states: warnings: explosion hazard.Do not use in presence of flammable anesthetics or gases.Do not submerge handle in liquid as this may compromise the efficiency of the pump or alter the ph of the liquid.Do not cut the battery pack cable.Cutting through the battery pack cable could lead to shock, excessive heat and/or sparks, and could result in fire and/or personal injury.Do not submerge the battery pack in liquid.Additionally, the tyvek lid for the individual pulsavacs devices states: warning: explosion hazard.Do not use in presence of flammable anesthetics or gases.Do not submerge in liquid as this may compromise the efficiency of the pump or alter the ph of the liquid.Do not cut the battery pack cable.Cutting through the battery pack cable could lead to shock, excessive heat and/or sparks, and could result in fire and/or personal injury.Do no submerge the battery pack in liquid.Use caution when removing batteries.The battery pack contains alkaline batteries.Exposure to the contents of an open or leaking battery or their combustion products could be harmful.Avoid skin and eye contact.Use neoprene or natural rubber gloves and safety glasses with side shields when handling batteries.The customer reported that the battery pack had been severed from the device after the procedure.Speculatively, the most likely cause for this incident is improper disposal of the device in contradiction of the ifu warnings by the customer.Recommended actions: the customer¿s personnel should have refresher training on the ifu for this product.The electrical wires of this device should never be cut or pulled out without the batteries being removed first.

• Brand Name: FAN SPRAY KIT
• Type of Device: PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FAN SPRAY KIT
• 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: jennifer hutchison ; 200 west ohio avenue; dover, OH 44622 ; 3303438801
• MDR Report Key: 5587638
• MDR Text Key: 44146666
• Report Number: 0001526350-2016-00044
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00515047500
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2016
• 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: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1