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

Model Number 320-20-00

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/20/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant device(s): 320-42-00, 6090474 - equinoxe reverse 42mm humeral liner +0; 320-10-10, 5471713 - equinoxe reverse tray adapter plate tray +10.

Event Description

As reported, this was a scheduled revision of a (b)(6) y/o male patient's equinox reverse shoulder.The revision was to replace the proximal humeral tray due to a loose or broken reverse torque defining screw.We found that the screw was intact and seemed to back out after the torque defining screw was broken off per the technique.

Manufacturer Narrative

Section h10: (h3) the revision reported was likely the result of not resecting enough bone to properly assemble the humeral tray to the humeral stem.This improper assembly of the humeral tray to the humeral stem likely did not allow the torque defining screw to be fully seated, resulting in the torque defining screw backing out and subsequently the humeral tray disassociating from the humeral stem.However, this cannot be confirmed as the explanted devices from the first revision were not returned for evaluation.

• Brand Name: EQUINOXE
• Type of Device: REVERSE TORQUE DEFINING SCREW KIT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9842210
• MDR Text Key: 189054696
• Report Number: 1038671-2020-00247
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086518
• UDI-Public: 10885862086518
• Combination Product (y/n): N
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2023
• Device Model Number: 320-20-00
• Device Catalogue Number: 320-20-00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention