MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQ REVERSE TORQUE DEFINING SCREW KIT

Catalog Number 320-20-00

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 01/28/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surger: (b)(6) 2016.Revision due to infection.

Manufacturer Narrative

The engineering evaluation noted that the revision reported was likely the result of infection, which is addressed in the product labeling under general surgical risks.However, this cannot be confirmed as the devices were not available for evaluation.

• Brand Name: EQUINOXE
• Type of Device: EQ REVERSE TORQUE DEFINING SCREW KIT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8332621
• MDR Text Key: 135935399
• Report Number: 1038671-2019-00078
• 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: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-20-00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR