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

Model Number	320-15-05
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/08/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1038671-2022-00342
• Device Sequence Number: 11963463
• Product Code: KWT
• UDI-Device Identifier: 10885862086495
• UDI-Public: 10885862086495
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 06/15/2026
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2022
• Supplement Date Received by Manufacturer: 10/31/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female