MAUDE Adverse Event Report: ZIMMER SPINE ARDIS INSERTER - 9MM

Model Number 3256-02

Device Problems Hole In Material (1293); Device Damaged by Another Device (2915); Positioning Problem (3009)

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

Event Date 08/12/2015

Event Type  malfunction  

Manufacturer Narrative

Review of information provided and analysis of the returned ardis inserters concluded that there is no evidence of a product defect or failure.Furthermore, device history record review and analysis of labeling for the returned devices did not find any deficiencies, and the complaint is unconfirmed.There was no patient impact or delay in surgery indicated, and the surgery was completed with another device.This is the final report that will be submitted associated with this incident and device.No additional action is required at this time.

Event Description

Same case as: 2184052-2015-00098 and 2184052-2015-00099.It was reported that two ardis 9mm inserters would not fully thread into cage.Effort created an enlarged graft hole making cage unusable.

• Brand Name: ARDIS INSERTER - 9MM
• Type of Device: ARDIS INSERTER - 9MM
• 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: 5103705
• MDR Text Key: 26919125
• Report Number: 2184052-2015-00097
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Report Date: 08/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3256-02
• Device Catalogue Number: 3256-02
• Device Lot Number: 78ZR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1