MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQUINOXE REVERSE LOCKING SCREW

Catalog Number 320-15-05

Device Problem Unstable (1667)

Patient Problem Pain (1994)

Event Date 07/31/2018

Event Type  Injury  

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: EQUINOXE REVERSE LOCKING SCREW
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 8312864
• MDR Text Key: 135239033
• Report Number: 1038617-2019-05015
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-15-05
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2018
• 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: 68 YR