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

Model Number N/A

Device Problems Difficult to Insert (1316); Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It is reported that during a znn tibial nail procedure, the guide wire gripper would not grip onto the wire.There were no adverse events reported as a result of this malfunction.

Manufacturer Narrative

This report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Dimensions taken are within specification.Item exhibits impact marks.The device's 3.0 mm hole fails to securely grip 00/47-2255-008-01 guide wire.However, the device's 2.4 mm hole securely grips 00/47-2255-008-00 guide wire.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: ZNN GUIDE WIRE GRIPPER
• Type of Device: PASSER, WIRE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7742653
• MDR Text Key: 115907770
• Report Number: 0001822565-2018-04047
• Device Sequence Number: 1
• Product Code: HXI
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/15/2019

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 Model Number: N/A
• Device Catalogue Number: 00249001200
• Device Lot Number: 63740075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/03/2018
• Initial Date FDA Received: 08/02/2018
• Supplement Dates Manufacturer Received: 02/13/2019
• Supplement Dates FDA Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1