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

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

Patient Problem Fall (1848)

Event Date 11/21/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant device(s): liner, humeral plate.

Event Description

As reported, the patient "reached over to shut off his cpap machine and something broke".The patient is a large male and has fallen several times in the past two years.On x-rays it looked as if the torque defining screw had sheared off.When the patient was opened, the screw fell right out, so it had not sheared off but potentially backed out.The liner, humeral plate and screw were revised.There were no complications and the surgery went perfectly.The surgeon was able to thread the explanted screw into the humeral plate and it was fine, nothing appeared to be stripped, so the surgeon doesn¿t know what happened.A new screw was opened and the surgeon was able to thread it.The rep stated that the surgeon and himself were able to thread the explanted screw into the humeral plate and it was fine, nothing appeared to be stripped, so they don¿t know what happened.They also opened a new screw and were able to thread it.The hospital has a policy where they keep explants and decontaminate and test them.

Manufacturer Narrative

This event was determined to be a duplicate of 1038671-2020-00247.Please see other report number for final evaluation.

• Brand Name: EQUINOXE
• Type of Device: SCREW
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9403965
• MDR Text Key: 168885579
• Report Number: 1038671-2019-00591
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR