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

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/23/2016

Event Type  malfunction  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported the grippers will not grip the wires.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

The returned product was confirmed to have wear that could potentially cause loss of function.As returned, the guide wire grippers exhibited wear and tear that indicates use.A functional test was performed using smooth guide wires.The device functioned as intended while using the first tested feature.The second tested feature did not grip and hold the guide wire.Dimensional measurements and material hardness are conforming to print specification.The device history records were reviewed and the records indicated that the device met specifications at the time of manufacture.The guide wire grippers had potential field ages of approximately 1 years and 2.5 years at the time of the reported incident.This device was used for treatment.Initial product history search conducted on august 30, 2016 revealed no additional complaints against the related part and lot combinations.The package insert included with the instrument has instructions for use, warnings, and precautions for the instrument.Some of these instructions are ¿end of life is normally determined by wear and damage due to use.Do not use cutting/sharp instruments with dull or deformed edges or instruments/provisionals that are deformed, corroded, damaged or worn.They may not perform as intended.If damage or wear is noted that may compromise the function of the instrument, do not use the device and contact your zimmer representative for a replacement.¿ the most likely cause of the instruments not gripping is wear and tear from use.

• Brand Name: ZIMMER ZNN GUIDE WIRE GRIPPER
• Type of Device: TRAUMA INSTRUMENT
• 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: 5748558
• MDR Text Key: 48134127
• Report Number: 0001822565-2016-02179
• 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: 06/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2016
• 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: 63017695
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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