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

Model Number N/A

Device Problems Overheating of Device (1437); Material Rupture (1546)

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

Event Date 10/22/2015

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 a customer in (b)(6) had batteries overheat in two pulsavacs when they tried to remove the batteries from the housing.Per communication to sales manager, there was a report of battery explosion (b)(6) 2015.

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 (ifu) 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 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: PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM 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: 5233282
• MDR Text Key: 31710283
• Report Number: 0001526350-2015-00192
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/13/2016

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 Model Number: N/A
• Device Catalogue Number: 00515047500
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/01/2015
• Initial Date FDA Received: 11/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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