MAUDE Adverse Event Report: EXACTECH, INC EQUINOXE SCREWS

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 11/09/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient presented with dislocation.The case report form indicates the event is unlikely related to devices and definitely related to the procedure.This event report was received through clinical data collection activities.

Manufacturer Narrative

Void this submission.

Event Description

Patient presented with dislocation.The case report form indicates the event is unlikely related to devices and definitely related to the procedure.This event report was received through clinical data collection activities.

• Brand Name: EQUINOXE SCREWS
• Type of Device: EQUINOXE SCREWS
• Manufacturer (Section D): EXACTECH, INC; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 6117794
• MDR Text Key: 60549801
• Report Number: 1038671-2016-00804
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2016
• 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
• Patient Age: 72 YR
• Patient Weight: 110