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

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 03/10/2015

Event Type  malfunction  

Manufacturer Narrative

Two guide wire grippers were sent in with this complaint for evaluation.Visual exams and functional tests were performed on both products.Manufacturing records and a technical evaluation showed the guide wire grippers were conforming to the specifications and material information sheet (mis).Both returned products show repeated use indicated by worn etching, dents and scratches, thread damage in one instrument, and guide wire hole damage in the other.The instruments had a potential field age of approximately 3.5 years at the time of incident with unknown usage history.This device is used for treatment.A functionality test was run on both products and one lot passed and the other lot failed, with use of a 3.0mm by 70cm guide wire.The failed product from the listed lot number is the part that exhibits hole elongation on both the top strike handle and the pivot plate.Based on information provided, the device has reached the end of its useful life.This issue has been investigated due to previous reports of this nature.A new design was released to increase the hardness of the strike plate and tighten the tolerance of the guide wire holes, which will improve gripping strength as well as durability.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 grippers allow wire to slip through them and are not gripping properly.

• Brand Name: ZNN GUIDE WIRE GRIPPER
• Type of Device: HXI
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5637106
• MDR Text Key: 44613504
• Report Number: 0001822565-2016-01491
• Device Sequence Number: 1
• Product Code: HXI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PN/A
• 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: 03/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00249001200
• Device Lot Number: 61877090
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1