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

Catalog Number 00249001200

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 06/29/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual inspection of the device confirms that there are deep gouges and sharp burrs on the top and bottom surfaces of the strike handle.It has also been noted that there is damage on the threaded rod and abrasion visible on the 3.0 mm hole.Functional test using plug gauges found the 2.4mm feature functioned as intended while the 3.0mm feature did not hold plug gauges as intended.Review of the device history record did not find any deviation or anomalies.Dimensions were found conforming to print specifications where measured.Hardness testing confirms the hardness to be within specification.The device had been in the field for approximately 6 years 4 months.It is unknown how many times the devices had been used during that time.This device is used for treatment.Noted damage on the threaded rod locking teeth may contributed to the reported event.The hole damage is likely from wear due to repeated usage.A new design has been released with changes to increase hardness of the strike plate and tighten tolerance of the guide wire holes.The goal of these changes is to improve gripping strength and durability, which will provide additional useful life from the device.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 device jams and slips.

• Brand Name: 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: 5569613
• MDR Text Key: 42607554
• Report Number: 1822565-2016-01093
• 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: Physician
• Type of Report: Initial
• Report Date: 06/30/2015

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: 61174680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2015
• Initial Date FDA Received: 04/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2009
• 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