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

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported that the patient was revised due to the coonrad morrey pin breaking.

Manufacturer Narrative

No devices or photos were returned therefore a determination on the condition of the components could not be made.The devices part numbers and lot numbers are unknown therefore a review of their device history records and a complaint search could not be performed.The devices were used for treatment.Multiple attempts were made for additional information however none has been received to date.With the provided information an exact cause could not be determined.

• Brand Name: UNKNOWN ZIMMER COONRAD MORREY PIN
• Type of Device: EXTREMITY 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: 5278898
• MDR Text Key: 33071449
• Report Number: 1822565-2015-02622
• 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
• 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
• 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
• Supplement Dates FDA Received: 02/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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