MAUDE Adverse Event Report: ZIMMER SPINE ARDIS INSERTER

Model Number 3256-01

Device Problem Failure To Adhere Or Bond (1031)

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

Event Type  malfunction  

Manufacturer Narrative

Event Description

It was reported that the cage could not be attached to the inserter.

Manufacturer Narrative

Visual analysis of the returned device confirmed the reported event.Review of information provided and analysis of the returned device concluded that there is no evidence of a product defect.Manufacturing records reviewed indicated no deviations or anomalies.It is not suspected that the product failed to meet specifications.This is the final report that will be submitted associated with this incident and device.No additional action is required at this time.The information contained herein is being provided to the fda to comply with regulations relating to medical device reporting and is based on information submitted by others that may not be factually correct.This submission does not constitute a determination or admission that a device has malfunctioned or that a device is related to a death or injury.

• Brand Name: ARDIS INSERTER
• Type of Device: ARDIS INSERTER
• Manufacturer (Section D): ZIMMER SPINE; 7375 bush lake road; minneapolis MN 55439
• Manufacturer (Section G): ZIMMER SPINE; 7375 bush lake road; minneapolis MN 55439
• Manufacturer Contact: rikke hanson ; 7375 bush lake road; minneapolis, MN 55439 ; 9528325600
• MDR Report Key: 5087056
• MDR Text Key: 26417033
• Report Number: 2184052-2015-00095
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3256-01
• Device Catalogue Number: 3256-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention