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 Type  malfunction  

Manufacturer Narrative

(b)(4).The returned device was confirmed to function incorrectly and exhibits wear and tear from indicated use.A functional test was performed using 2.4mm and a 3.0mm smooth guide wires.The device functioned as intended while using the 2.4mm feature.The 3.0mm feature did not grip and hold the 3.0mm guide wire.Gouging is seen in the 3.0mm hole.This feature measured oversized.The device history records were reviewed and the records indicated that the parts met specifications at the time of manufacture.The guide wire gripper had a potential field age of approximately 3 years and 3 months at the time of incident.The package insert included with the instrument specifies that the device may not perform as intended if damaged or worn.Due to the condition of the returned guide wire gripper, the most likely cause of the instrument not gripping 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: 5566193
• MDR Text Key: 42534022
• Report Number: 1822565-2016-01081
• Device Sequence Number: 1
• Product Code: HXI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 08/16/2015

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: 62314682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/16/2015
• Initial Date FDA Received: 04/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2013
• 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