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

Catalog Number 320-20-00

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Disorder (2373)

Event Date 03/05/2018

Event Type  Injury  

Manufacturer Narrative

In a review of the labeling it is a known complication that a patient's age, weight, or activity level 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 instability of the shoulder joint device is related to patient underlying conditions to include obesity, cardiac diseases that inhibit healing and chronic left shoulder maladies.This device is used for treatment, not diagnosis.

Event Description

Information reported is via ufr# (b)(4).No additional information provided.This is one of five products involved with the reported event and the associated manufacturer report numbers are 1038671-2018-00475, 1038671-2018-00476, 1038671-2018-00477, 1038671-2019-05004.

• Brand Name: EQ REVERSE TORQUE DEFINING SCREW KIT
• Type of Device: TORQUE DEFINING 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 ; 3523782617
• MDR Report Key: 8256280
• MDR Text Key: 133358571
• Report Number: 1038671-2019-05005
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 09/24/2022
• Device Catalogue Number: 320-20-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2019
• Date Device Manufactured: 09/25/2017
• 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