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

Catalog Number 320-20-00

Device Problems Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Pain (1994); Joint Disorder (2373)

Event Date 07/31/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Revision due to pain and joint instability.

Manufacturer Narrative

The engineering evaluation noted the revision was likely the result of loose supporting ligaments, which led to joint instability and pain.

Event Description

Revision due to pain and joint instability.

• Brand Name: EQUINOXE
• Type of Device: EQ REVERSE TORQUE DEFINING SCREW KIT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7757303
• MDR Text Key: 116250163
• Report Number: 1038617-2018-00649
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2019
• 2 Devices were Involved in the Event: 1 2

2 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 08/06/2018
• Initial Date FDA Received: 08/07/2018
• Supplement Dates Manufacturer Received: 08/06/2018
• Supplement Dates FDA Received: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR