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); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Battery Problem (2885)

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

Event Date 10/19/2016

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 initially reported that the hospital staff took lavage through the back and opened up the battery pack to remove the batteries.At this point it exploded.This was then found to be the case due because of cutting through the wires.The sales representative has advised that training will be provided on disposal of the system and provide laminates and screwdrivers.

Manufacturer Narrative

(b)(4).The device history record (dhr) review was performed for part number 00-5150-475-01, lot 63423686.This lot was manufactured and released into inventory on (b)(6) 2016.There were no non-conformances, requests for deviations (rfd¿s) or other reported spontaneous anomalies reported for this production lot.All testing and inspection requirements were performed and accepted.Visual examination of the product could not be performed because no product was returned for this complaint.A stock investigation is not applicable.The inventory for the lot relevant to this complaint has been exhausted.Pulsavac is manufactured in accordance.The manufacturing process was reviewed and there were no issues identified as a possible cause for this complaint.100% of the pulsavac units are tested online to ensure proper operation.Quality inspections and tests are performed in accordance.Quality assurance performs functional and performance testing on a representative sample.Each pulsavac device is cycled through both the high speed mode and low speed mode two times as defined by the work instructions.The customer claimed that they cut the wire in order to retrieve the batteries at a later time.Cutting the wire can lead to a battery rupture.However, without the returned product the specific nature of the battery rupture cannot be confirmed, therefore a true root cause cannot be established.

• 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: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6109890
• MDR Text Key: 60685307
• Report Number: 0001526350-2016-00130
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 00515047500
• Device Lot Number: 63423686
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2016
• 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