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

Catalog Number 00249001200

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Other device used: catalog #00249001200, guide wire gripper, lot #61241811.This report will be amended when our investigation is complete.

Event Description

It is reported the guide wire grippers would not grab the wires as intended.

Manufacturer Narrative

This report is being amended to reflect changes in sections.Two sets of wire grippers were alleged to insufficiently grip guide wires.There was no resulting harm to the patient and revision surgery was not performed.Surgery was delayed by 15 minutes.The devices were used for treatment.The wire grippers were evaluated via visual examination, dimensional analysis, and functional tests.Visible dents and signs of wear on the pivot hole, strike handle, and teeth of threaded rod are indicative of use over their potential field ages of 6 years 8 months and 3 years 7 months.Review of device history records and inspection reports for both devices indicated that they were manufactured to specifications.Based on the information provided, the probable cause of failure for both devices is wear from use.

• 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: 5408401
• MDR Text Key: 37716391
• Report Number: 1822565-2016-00200
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2016
• 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: 62056102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2012
• 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