MAUDE Adverse Event Report: ZIMMER INC, GUIDE WIRE GRIPPER; HXI

Catalog Number 00249001200

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation.The reported condition was confirmed.Visual inspection of the product concluded dents are visible on the top and bottom surfaces of the gripper, indicating previous use.Damage was also noted to the threads and wear and elongation was evident on the 3mm hole.Manufacturing records for this lot were reviewed and did not indicate any manufacturing anomalies.The guide wire grippers were dimensionally analyzed and found to be within specification where measured.The device was used for treatment.The cause of the complaint was likely due to the wear and elongation of the 3.0mm hole in the pivot plate caused by normal use of the device over an extended amount of time.The gripper has a potential field age of over 4.5 years with an unknown number of uses.This product will be monitored for any adverse complaint trends.This mdr was identified during an internal retrospective review to meet reporting requirements and therefore is being filed retrospectively.

Event Description

It was reported that the guide wire gripper does not have any more tension and does not hold the wire.

• Brand Name: GUIDE WIRE GRIPPER
• Type of Device: HXI
• Manufacturer (Section D): ZIMMER INC,; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5572494
• MDR Text Key: 42493437
• Report Number: 1822565-2016-01033
• Device Sequence Number: 1
• Product Code: HXI
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/11/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00249001200
• Device Lot Number: 61107858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2013
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/11/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2009
• 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