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

Catalog Number 00249001200

Device Problem Device Inoperable (1663)

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

Event Date 08/17/2016

Event Type  malfunction  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that the guide wire gripper does not grip the wire.The surgery was completed using a different device.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.The returned product was confirmed to have wear that could potentially cause loss of function.As returned, the guide wire gripper exhibited wear and tear that indicates use.A functional test was performed using 2.4mm and a 3.0mm smooth guide wires.The device functioned as intended while using the 2.4mm feature.The 3.0mm feature did not grip and hold the 3.0mm guide wire.The device history records were reviewed and the records indicated that the device met specifications at the time of manufacture.The guide wire gripper had a potential field age of approximately 7 years at the time of the reported incident.This device is used for treatment.Per the package insert, ¿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: GUIDE WIRE GRIPPER
• Type of Device: HIP 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: 5946095
• MDR Text Key: 54554113
• Report Number: 0001822565-2016-03242
• 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: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2016
• 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: 61107858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1