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

Model Number N/A

Device Problem Difficult to Advance (2920)

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

Event Date 04/01/2016

Event Type  malfunction  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported the guide wire gripper would not engage and grip the guide wire during use in surgery.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

Device history records were previously reviewed with no deviations or anomalies identified that would have contributed to the reported event.Product was returned for evaluation.Visual inspection revealed thread damage on the threaded rod.Two pins were identified to be loose.Impact marks were visible on both the superior and inferior surface.Dimensions were found conforming to print specifications where measured.The hardness of the top strike handle was found to be conforming.This device is used for treatment.The device had a potential field age of approximately four years.It is also unknown how many times the device had been used during that time.A definitive root cause cannot be determined with the information provided.

• Brand Name: ZIMMER NATURAL NAIL 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: 5627603
• MDR Text Key: 44576675
• Report Number: 0001822565-2016-01388
• 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,Followup,Followup
• Report Date: 04/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2016
• 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: 62006692
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2012
• 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