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

Model Number 3256-02

Device Problems Material Deformation (2976); Positioning Problem (3009)

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

Event Date 02/03/2015

Event Type  malfunction  

Event Description

Same case as: 2184052-2015-00018.It was reported that an ardis implant was cross threaded onto an inserter, the implant disengaged from the inserter during implantation.

Manufacturer Narrative

It is indicated that the device will not be returned for eval.Review of info provided concluded that there is no info provided concluded that there is no evidence of a prod defect.This is the final report that will be submitted associated with this incident and device.No add'l action is required at this time.

• Brand Name: ARDIS INSERTER - 9MM
• Type of Device: ARDIS INSERTER - 9MM
• Manufacturer (Section D): ZIMMER SPINE; 7375 bush lake rd.; minneapolis MN 55439
• Manufacturer Contact: scott lapointe ; 7375 bush lake rd.; minneapolis, MN 55439 ; 9528325600
• MDR Report Key: 4597502
• MDR Text Key: 5630835
• Report Number: 2184052-2015-00014
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2015
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 64 YR