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

Catalog Number 00249001200

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information was received from a distributor who is not required to complete form 3500a.Device return condition noted impact damage on the impaction zones on top and bottom of the product.Threads were damaged and a few scratches were along the side of the product.The device met print specifications where measured.For functional testing, 3.0 and 2.4 mm guide wires were placed in a vice and the guide wire gripper was locked down on the guide wire and hit with a mallet.In both cases the guide wire gripper slid down the guide wire.Device history records review found lot conformed at the time of manufacture.The approximate lifetime of the device is 4 years.It is unknown how many times device was used during that timespan.The device is used for treatment.The root cause of the complaint appears due to normal wear to the device over its approximate 4 year lifetime.The device reached the end of its useful life.This mdr was identified during an internal retrospective review to meet reporting requirements and therefore is being filed retrospectively.

Event Description

It was reported during surgery, the guide wire gripper was not functioning properly and would not tension wires as expected.Cannot be properly jammed and slides through guide wires.In addition, subcomponents on the instrument appear to be loosened.

• 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: 5570014
• MDR Text Key: 42984295
• Report Number: 1822565-2016-01199
• Device Sequence Number: 1
• Product Code: HXI
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/11/2016

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: Health Professional
• Device Catalogue Number: 00249001200
• Device Lot Number: 61571812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/11/2014
• Initial Date FDA Received: 04/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2010
• 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