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

Catalog Number 00249001200

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 08/30/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The returned device was confirmed to have loss of function and exhibit wear and tear from indicated use.The device functioned as intended by holding sufficiently the 2.4mm wire, but did not pass with the 3mm wire.The device was measured against the print specifications at several dimensions and it was confirmed that all measurements taken were within specification.The device history records were reviewed and the records indicated that the device met specifications at the time of manufacture.This device is used for treatment.The package insert included with the instrument specifies that the device may not perform as intended if damaged or worn.The most likely cause of the instrument not gripping the 3mm wire is wear and tear from use.This mdr was identified during an internal retrospective review to meet reporting requirements and therefore is being filed retrospectively.

Event Description

It is reported that the instrument failed to grip the guide wire.

• Brand Name: ZIMMER ZNN GUIDE WIRE GRIPPER
• Type of Device: HXI
• Manufacturer (Section D): ZIMMER INC; po box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; po box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5566569
• MDR Text Key: 42963160
• Report Number: 1822565-2016-01072
• 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
• Report Date: 09/11/2015

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: 62965706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2015
• Initial Date FDA Received: 04/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2015
• 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