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

Model Number N/A

Device Problems Burst Container or Vessel (1074); Material Discolored (1170); Smoking (1585); Expulsion (2933)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2017

Event Type  malfunction  

Manufacturer Narrative

The product will not be returning to the manufacturer for evaluation; however the investigation was not completed at the time of this report.A follow up medwatch will be submitted once the investigation is complete.

Event Description

It was initially reported that the pulsevac plus had been used for lavage in a total hip arthroplasty (tha) case.At case completion, the nurse was removing the lavage from the sterile field.Head surgical nurse (hsn) separates the battery pack from spray nozzle for disposal.Batteries are recycled and nozzle is disposed in trash.The nurse cut the wire with scissors at which point the battery pack "popped" and smoked a bit.The battery pack was opened; the batteries were black and two batteries had exploded.The pack was disposed of in a metal bin direct to the garbage.Additional information was received on (b)(6) 2017 stating that the event occurred after the completion of the surgery and there was no patient or user harm, injury or adverse event.There was no extension in surgery time and an alternate device was not required for use.The surgical technique for the device was not utilized as the instructions for use state not to cut the wires.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Review of the device history record could not be performed as no lot number was reported for this complaint.Although, product examination could not be performed as no product was returned for this complaint, the complaint is confirmed based on the account admitting that the nurse cut the wire to the battery pack with scissors.The reported event claimed that the wire had been cut and the battery pack ruptured shortly thereafter.It is known that cutting the wire can create a short circuit within the battery pack.The pulsavac ifu states, ¿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.¿ the root cause for this complaint is that the customer cut the wire, creating a short circuit within the battery pack.This short circuit caused the reported event.

• Brand Name: COMPONENT KIT
• Type of Device: PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM
• 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: 6294473
• MDR Text Key: 66562738
• Report Number: 0001526350-2017-00062
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• 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: 00515042001
• Device Lot Number: UNKNOWN
• Other Device ID Number: 00889024375130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2017
• 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: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1