MAUDE Adverse Event Report: ZIMMER INC NEXGEN MIS ADJUSTABLE INTRAMEDULLARY ROD

Catalog Number 00596704200

Device Problem Collapse (1099)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2014

Event Type  malfunction  

Event Description

It is reported that after routine placement of the im femoral rod it was noted the plate was not in contact with the femoral condyles.The surgeon, with the help of the scrub nurse, struggles for approximately 30 minutes to remove the im rod.The im rod was damaged during this process.Surgery continued using the shorter im rod with a good result and no effect to the pt.

Manufacturer Narrative

This report will be amended when our investigation is complete.

• Brand Name: NEXGEN MIS ADJUSTABLE INTRAMEDULLARY ROD
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 070
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4109704
• MDR Text Key: 4721239
• Report Number: 1822565-2014-01099
• Device Sequence Number: 1
• Product Code: FZX
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00596704200
• Device Lot Number: 61119862
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1