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

Model Number 320-15-05

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 03/08/2022

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant device(s): 320-35-02, 6960981 - small superior augment glenoid plate; 320-31-36, 6917056 - glenosphere, 36mm.No information provided in the following section(s).

Event Description

As reported, approximately 5 months post op the initial rtsa, this female patient was revised.The glenosphere locking screw was broken causing the glenosphere to disassociate from the glenoid baseplate.Surgeon replaced the glenosphere, glenoid, humeral tray and humeral liner.Event started by doing normal, everyday activities.Female patient was last known to be in stable condition following the event.No other patient information/medical history reported.

Manufacturer Narrative

Section h10: (h3) the revision reported was likely the result of both the screw being cross-threaded in the baseplate and bone graft or allograft being retained in the screw-hole threads, which led to incomplete seating of the glenosphere locking screw and glenosphere at the time of implantation.The system is intended to transmit forces through the glenosphere to the glenoid baseplate.When not fully seated, it is possible for the forces to be transmitted thought the glenosphere and the screw, creating forces on the screw that cannot be supported.

• Brand Name: EQUINOXE
• Type of Device: REV LOCKING SCREW
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 13975678
• MDR Text Key: 288361634
• Report Number: 1038671-2022-00342
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086495
• UDI-Public: 10885862086495
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 320-15-05
• Device Catalogue Number: 320-15-05
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2022
• Initial Date FDA Received: 04/01/2022
• Supplement Dates Manufacturer Received: 10/31/2022
• Supplement Dates FDA Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2021
• 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
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female