MAUDE Adverse Event Report: ZIMMER INC UNKNOWN ZIMMER COONRAD MORREY PIN; ELBOW PROSTHESIS

Catalog Number 32810502900

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 12/08/2015

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 the breakage of a pin.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

As returned the bushings are damaged, the inner pin fractured at its tines and the outer pin is worn.The device part and lot numbers are unknown; therefore, the devices could not be dimensionally inspected to their known print specifications.Additionally due to lack of part and lot numbers, neither device history records nor complaint history could be reviewed.The device was used for treatment.Failures of this type were investigated in a previous corrective and preventive action (capa).As a result of this capa, the design of the inner pin was modified in 2010 to increase the performance of the pins.Based on design of the returned inner pin, it was produced prior to design modification.

• Brand Name: UNKNOWN ZIMMER COONRAD MORREY PIN
• Type of Device: ELBOW PROSTHESIS
• 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: 5351313
• MDR Text Key: 35277103
• Report Number: 1822565-2016-00047
• 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: 12/14/2015

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2015
• Initial Date FDA Received: 01/07/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/10/2016; 03/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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