MAUDE Adverse Event Report: EXACTECH INC. OPTETRAK HI-FLEX FEMORAL COMPONENT

Catalog Number 244-02-02

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 06/30/2014

Event Type  malfunction  

Event Description

Revision of optetrak knee components, reason not reported.This event occurred outside of the us, in (b)(6), and was discovered as part of active surveillance.

Manufacturer Narrative

The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.

• Brand Name: OPTETRAK HI-FLEX FEMORAL COMPONENT
• Type of Device: FEMORAL COMPONENT
• Manufacturer (Section D): EXACTECH INC.; 2320 n.w. 66th ct.; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 n.w. 66th ct.; gainesville, FL 32653
• MDR Report Key: 4764578
• MDR Text Key: 21465419
• Report Number: 1038671-2015-00203
• Device Sequence Number: 1
• Product Code: HSA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 244-02-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/10/2015
• 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