MAUDE Adverse Event Report: ZIMMER INC ZIMMER COONRAD MORREY PIN; JDC

Catalog Number 32810502900

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Information was received from a foreign source who is not required to complete form 3500a.(b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported the patient was revised due to a broken connector pin.

Manufacturer Narrative

This report is being amended to reflect changes in sections.This report will be amended when our investigation is complete.

Manufacturer Narrative

No devices or photos were returned therefore a determination on the condition of the components could not be made.Review of the device history records did not find any deviations or anomalies.The device was used for treatment.No other complaints of any type have been received for this lot.With the provided information an exact cause could not be determined.

• Brand Name: ZIMMER COONRAD MORREY PIN
• Type of Device: JDC
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5279198
• MDR Text Key: 33124407
• Report Number: 1822565-2015-02621
• Device Sequence Number: 1
• Product Code: JDC
• 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: 11/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 32810502900
• Device Lot Number: 61591763
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2015
• Initial Date FDA Received: 12/09/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/12/2016; 02/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention