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

Catalog Number 00249001200

Device Problem Use of Device Problem (1670)

Patient Problem No Code Available (3191)

Event Date 02/13/2014

Event Type  malfunction  

Manufacturer Narrative

Information was received from a surgeon who is not required to complete form 3500a.The product was returned for evaluation.Photo and visual examinations reported normal wear and cosmetic damage on the product.Product was showing signs of tool marks on both the top and bottom indicating use.The 3.0mm hole was found to be worn and slightly out of shape.The 2.4mm hole was not worn, as it was likely used less frequently.Upon inspection, worn evidence was also noted by thread damage where the product locks in place.Functional tests and measurements performed on the product by methods; such as, pin gages, caliper, rockwell hardness test, and micrometer.All dimensions measured met print specifications.The device history records reviewed found device to be conforming at the time of manufacture.The device is roughly 3.5 years old.This device is used for treatment.The most likely cause of the instrument not gripping is normal wear from use; the device has 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 that the guide wire gripper no longer gripped 3.0mm guide wire.

• Brand Name: ZIMMER ZNN GUIDE WIRE GRIPPER
• Type of Device: HXI
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5569524
• MDR Text Key: 42438896
• Report Number: 1822565-2016-01037
• 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: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/17/2014

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: Health Professional
• Device Catalogue Number: 00249001200
• Device Lot Number: 61571817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/17/2014
• Initial Date FDA Received: 04/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2010
• 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