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

Catalog Number 00249001200

Device Problem Difficult to Insert (1316)

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

Event Date 06/28/2016

Event Type  malfunction  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It was reported that the surgeon tried to insert the wire into the guide wire gripper, but the wire was not being gripped.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

Device history records were reviewed with no deviations or anomalies identified that would have contributed to the reported event.The guidewire gripper was returned for review.Visual inspection revealed impact marks on the superior surface.A functional check confirmed that the 2.4mm hole securely gripped a 00/47-2255-008-00 guide wire, but the 3.0 mm hole failed to securely grip a 00/47-2255-008-01 guide wire.The threaded locking knob was also observed to bind.This device is used for treatment.Based on the order running complete, it is believed the part was conforming when it left zimmer biomet.The instrument/provisional use, care and sterilization package insert states to inspect all product and ¿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 guidewire gripper was manufactured on 30 jan 2014 and therefore had potential field age of approximately 2 years 4 months, with the exact usage unknown.The most likely cause of the instruments not gripping is wear and tear from use.

• Brand Name: 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: 5841314
• MDR Text Key: 50980253
• Report Number: 0001822565-2016-02608
• 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: 07/05/2016

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: 62597689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2016
• Initial Date FDA Received: 08/02/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/13/2016; 10/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2014
• 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