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

Model Number 320-20-00

Device Problems Device Dislodged or Dislocated (2923); Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/21/2020

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

As reported, approximately 21 months after the initial right tsa, this (b)(6) y/o female patient, was scheduled for a revision due to scapular notching and dislocation.During the revision the 38 +0 humeral liner was exchanged for a 42 +2.5.However, because the screw had been partially unscrewed the surgeon had to burr out the back of the poly so that it would seat into the tray.Approximately 30-45 mins was added to the case time to resolve the issue.The device will not be returned as it is implanted in the patient.Patient was last known to be in stable condition following the event.This event happened during a revision which is being captured under (b)(4).

Manufacturer Narrative

The stripped screw reported was likely the result of the torque defining screw becoming stripped with the humeral stem, preventing the screw from being disassembled.However, this cannot be confirmed because the component was not returned for evaluation as it remained implanted.

• 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: 10647978
• MDR Text Key: 210375857
• Report Number: 1038671-2020-00564
• 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: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 320-20-00
• Device Catalogue Number: 320-20-00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR