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

Catalog Number 300-20-02

Device Problems Loose or Intermittent Connection (1371); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); No Known Impact Or Consequence To Patient (2692)

Event Date 08/16/2017

Event Type  Injury  

Manufacturer Narrative

The contribution of the devices to the experience reported could not be determined as the device was not returned.Pending evaluation.

Event Description

Index surgery: (b)(6) 2012.Revision due to patient fall, causing the poly to become loose on the glenoid side.

Event Description

Due to an insufficient rotator cuff, the surgeon had decided to remove all the primary components, except for the humeral stem and perform a reverse shoulder.No additional information provided.This is one of four products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00627, 1038671-2017-00629 and 1038671-2017-00630.

Manufacturer Narrative

In a review of the labeling it is a known complication that a patient's age, weight, activity level, or trauma would cause the surgeon to expect early failure of the system.Revisions or surgical interventions are a known complication found in joint replacements.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The most likely cause of the revision for the shoulder joint device is related the patient fall.This device is used for treatment, not diagnosis.

• Brand Name: "EQUINOXE TORQUE DEFINING SCREW SQUARE DRIVE KIT
• Type of Device: SCREW KIT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 6812926
• MDR Text Key: 83365400
• Report Number: 1038671-2017-00628
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K042021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/28/2017
• Device Catalogue Number: 300-20-02
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR