MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Injury (2348)

Event Date 04/20/2011

Event Type  Injury  

Manufacturer Narrative

This event report was received through clinical data collection activities.The revision reported was likely the result of rotator cuff tear.

Event Description

Index surgery: (b)(6) 2009.Revision due to subscapularis tear.The case report form indicates this event is possibly related to devices and definitely related to procedure.

Manufacturer Narrative

The revision reported was likely the result of rotator cuff tear.

• Brand Name: EQUINOXE
• Type of Device: EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8270192
• MDR Text Key: 133836603
• Report Number: 1038671-2019-00004
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 66