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 08/26/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The returned device exhibits wear and tear that indicates use.A functional test was performed using 2.5mm and 3.0mm smooth guide wires.The device functioned as intended by holding sufficiently both the 2.5mm and 3mm wires.There is some damage noted around the 3.0mm hole as well as on the thread of the threaded rod.The product was measured against the print specifications at several dimensions and it was confirmed that all measurements taken were within specification.Device history records were reviewed and the records indicated that the device met specifications at the time of manufacture.The guide wire gripper had a potential field age of approximately 5 years and 3 months at the time of incident.The device is used for treatment.The package insert included specifies that the device may not perform as intended if damaged or worn.Although the device passed the functionality test, the guide wire gripper having wear damage on the threads and around the 3mm hole has potential to compromise the function of the device; therefore, 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 during surgery.

• Brand Name: ZIMMER ZNN 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: 5569637
• MDR Text Key: 42976001
• Report Number: 1822565-2016-01063
• 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: 09/03/2015

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: 61571812
• 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: 09/03/2015
• 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