MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. FAN SPRAY KIT

Model Number N/A

Device Problem Burst Container or Vessel (1074)

Patient Problems Eye Burn (2523); Superficial (First Degree) Burn (2685)

Event Date 10/12/2015

Event Type  Injury  

Manufacturer Narrative

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 reported that after washing, the nurse took device to throw it out.At that point, there was an explosion of batteries.The explosion caused 1st degree burns of the cornea of nurse eye.

Manufacturer Narrative

A device history records review was performed for part number 00-5150-475-00, lot 63028344.This device was manufactured at zimmer surgical and placed into inventory on (b)(6) 2015.There were no related non-conformances, change notices, reworks, request for deviations or any other spontaneous anomalies reported.A photograph was provided showing the catastrophic failure of the battery pack.The photograph showed that the electrical wire had been severed.All of the batteries appear to have ejected the anode or split open.On 12/7/2015 the battery pack was received from the customer.The battery pack was returned with the tyvek tray lid which identified the production lot number that was not previously reported.The visual inspection of the battery pack confirmed what was depicted in the photograph.Only the battery pack was returned and it was too damaged for any functional testing.The review of the design and manufacturing processes noted no systemic issues relevant to this complaint.The customer's reported event was that the nurse picked up the battery pack after washing to throw it out when it exploded.The photograph depicts a catastrophic failure of the battery pack.All of the batteries had either ejected their anode or split open.The battery pack and the photograph also show that the electrical wire had been severed.Historically, 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 pulsavac hand-piece is normally exposed to biological fluids and as such would be treated as a bio hazardous material after the procedure.Since, the battery pack was sitting waiting for disposal; it is most probable that the electrical wires were severed to remove the battery pack from the hand-piece.Speculatively, the most likely cause for this incident is improper disposal of the device in contradiction of the instructions for use 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.

• Brand Name: FAN SPRAY KIT
• Type of Device: 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: 5200296
• MDR Text Key: 30335563
• Report Number: 0001526350-2015-00187
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2015
• Is this an Adverse Event 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2015
• 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
• Patient Outcome(s): Other