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

Model Number N/A

Device Problems Expulsion (2933); Material Deformation (2976)

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

Event Date 02/08/2018

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Product has not been received by zimmer biomet and the investigation will begin once product is received.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that fever and deformation occurred on the zimmer pulsavac plus battery pack of the in the hospital.The cable of the battery pack has already cut off.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

(b)(4).This medwatch is being filed to relay additional information.Review of the device history record identified no relevant deviations or anomalies.Product examination found that only the battery pack was returned for this complaint.The batteries inside the battery pack had warped due to a short circuit.This complaint is confirmed.However, the wire was cut by the customer.A review using the p/n of this complaint and also based upon open and closed complaints and the keyword search using the character string ¿deform¿ between (b)(6) 2018 to (b)(6) 2018 resulted in 2 complaints.A review using the criteria of p/n and complaint category of this complaint and also based upon open and closed complaints and the keyword search using the character string ¿deform¿ and sorted by manufacturer date was performed.This review resulted in the highest occurrence for a given manufacture date was 1.The reported event claimed that the battery wire of the unit was cut and later on the battery pack became hot and close to combustion.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.¿ ca-03500 is in process to directly address customers cutting the battery cable.The root cause of the reported event is that the customer cut the wire.Cutting the wire has the risk of causing a short circuit of the battery pack.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

• 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: 7276255
• MDR Text Key: 100266928
• Report Number: 0001526350-2018-00153
• 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
• Report Date: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 00515048201
• Device Lot Number: 63698533
• Other Device ID Number: 00889024375192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1