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

Model Number N/A

Device Problems Overheating of Device (1437); Battery Problem (2885)

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

Event Date 01/12/2017

Event Type  malfunction  

Manufacturer Narrative

The product will not be returning to the manufacturer for evaluation; however 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 initially reported that the battery pack from pulse lavage had been cut off and the retained battery pack overheated and was close to combustion.

Manufacturer Narrative

The complaint is being reported by zimmer biomet as (b)(4).This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Review of the device history record could not be performed as no lot number was reported for this complaint.Product examination could not be performed as no product was returned for this complaint.This complaint is non-verifiable.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.¿ however, because no product was returned for this complaint, the root cause cannot be specifically determined with the provided information.

• 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: 6294440
• MDR Text Key: 66560330
• Report Number: 0001526350-2017-00060
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/26/2017

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 Model Number: N/A
• Device Catalogue Number: 00515048200
• Device Lot Number: UNKNOWN
• Other Device ID Number: 00889024375185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2017
• Initial Date FDA Received: 02/01/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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