MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. HIP KIT; LAVAGE, JET

Model Number N/A

Device Problems Device Operates Differently Than Expected (2913); Expulsion (2933)

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

Event Date 10/25/2016

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 battery pack exhibited expulsion during surgery.Additional information received from the customer on november 2, 2016 stated that the product failure occurred after surgery during clean up (after the completion of surgery).

Manufacturer Narrative

This complaint is being reported by zimmer biomet as (b)(4).Review of the device history record identified no deviations or anomalies.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.Using view 3.2 from the etq reliance system, from october 26, 2015 to october 25, 2016, there were 16 closed complaints that used the same risk management file as part of their respective risk assessment.The scope of this search includes all part numbers contained within the same risk management file.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.¿ a corrective action is in process to directly address customers cutting the battery cable.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.

Manufacturer Narrative

(b)(4).

• Brand Name: HIP KIT
• Type of Device: LAVAGE, JET
• 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: 6126190
• MDR Text Key: 61092930
• Report Number: 0001526350-2016-00134
• 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,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/17/2017

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: 04/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 00515048200
• Device Lot Number: 63331509
• Other Device ID Number: 00889024375185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2016
• Initial Date FDA Received: 11/23/2016
• Supplement Dates Manufacturer Received: 07/09/2017; 07/17/2017
• Supplement Dates FDA Received: 07/13/2017; 07/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2016
• 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