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

Catalog Number 00249001200

Device Problems Device Operates Differently Than Expected (2913); Material Deformation (2976)

Patient Problem No Information (3190)

Event Date 12/06/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received for evaluation.The gripper would properly hold a.0945" pin in the 2.4mm hole and a.1185 inch gage pin in the 3.0mm hole.Elongation of hole feature was noted.Dents and scratches are visible on the top and bottom surfaces of the gripper indicating previous effective use.Abrasion was also visible on the 3.0mm holes in the handle and pivot plate.The device showed heavy wear.During functional testing, the device allowed a 3mm guide wire to slip when heavy load was applied to the wire.Manufacturing records of the lot show that the device was manufactured within specification.The device was used for treatment.The probable cause for the elongation of hole feature is likely wear due to normal use.The gripper has a potential field age of approximately 2 years with an unknown number of uses.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 guide wire tensioner no longer tensions guide wire.

• Brand Name: 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: 5572531
• MDR Text Key: 42989570
• Report Number: 1822565-2016-01113
• 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: 12/11/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2016
• 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: 61962249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/11/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2012
• 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