MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. HIP KIT; PULSAVAC PLUS AC HIP KIT

Model Number N/A

Device Problems Leak/Splash (1354); Battery Problem (2885)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 12/09/2016

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 is reported that during the surgery, the product was working only when the switch was in the low mode.Therefore, the surgeon used an alternative one to complete the surgery.After the product was received, it was found the battery was leaking.

Event Description

Review of the information on (b)(6) 2017 determined that the event occurred during surgery on (b)(6) 2016.There was no harm, injury or adverse event to the patient or operator and there was no medical intervention/additional surgical procedure required.There was no delay in surgery and an alternate device was retrieved to complete the surgery.There were no contributing conditions related to the event and the proper surgical technique was utilized.

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).This follow-up report is being submitted to relay additional information.Review of the device history record for 00515048201, lot number 63171222, identified no deviations or anomalies.The device was received in a inoperational state in that the device would not function.Further product examination observed that the battery pack had been damaged from leaking batteries, as shown in attached photos.The complaint is confirmed.It was not discernible if a wire was shorted due to the amount of battery rupture contamination, therefore, based on the information that was provided along with product examination, the root cause of the reported event could not be specifically determined.

• Brand Name: HIP KIT
• Type of Device: PULSAVAC PLUS AC HIP 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: 6228574
• MDR Text Key: 64435496
• Report Number: 0001526350-2017-00005
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 07/07/2017

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 Expiration Date: 09/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 00515048201
• Device Lot Number: 63171222
• Other Device ID Number: 00889024375192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2016
• Initial Date FDA Received: 01/06/2017
• Supplement Dates Manufacturer Received: Not provided; 06/29/2017
• Supplement Dates FDA Received: 02/01/2017; 07/07/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/12/2015
• 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