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

Information was received from a distributor who is not required to complete form 3500a.Device was returned for exam.The product received condition was described as light cosmetic damage.One device was returned with scratches on the top and bottom indicative of use.Thread damage was noted where the product can be locked in place to hold a guidewire.The 3.0mm and 2.4mm holes did not appear worn or damaged during visual inspection without magnification.The wire grippers were evaluated by visual examination, dimensional analysis, and functional tests; such as, visual, pin gages, micrometer, caliper and rockwell hardness test.Print specifications were met for device.Device history records were previously reviewed and found conforming to requirements at the time of manufacture.Lot was previously reviewed and found conforming per complaint.The device is roughly 5 years old.The device is used for treatment.The device has reached the end of its useful life.This failure mode has been previously reported.A new design is being tested that increases the hardness of the strike plate and tightens the tolerance of the guide wire hole.This will provide additional useful life from the device.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 no longer tightens the guide wires as intended.

• 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: 5571319
• MDR Text Key: 42984306
• Report Number: 1822565-2016-01160
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2014

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: Other
• Device Catalogue Number: 00249001200
• Device Lot Number: 61231404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/19/2014
• Initial Date FDA Received: 04/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1