MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE 46MM GLENOSPHERE

Model Number	320-01-46
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/11/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 5 months postop the initial right tsa, this(b)(6) male presented with broken screws in the right shoulder and was revised approximately 3 months later.At that time, the outcome was reported as resolved.The case report form indicates this event is definitely related to devices and possibly related to procedure.This event report was received through clinical data collection activities.Devices were not returned per study protocol.
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 300-01-13 - equinoxe, humeral stem primary, press fit 13mm, 320-46-00 - equinoxe reverse 46mm humeral liner +0, 320-10-00 - equinoxe reverse tray adapter plate tray +0, and 320-15-04 - rs glenoid plate r post aug, 8 deg, right.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of breakage of one or more of the screws used.However, not enough information was provided to determine which screw(s) fractured or the cause of the fracture.

• Brand Name: EQUINOXE
• Common Device Name: REVERSE 46MM GLENOSPHERE
• 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: 13003559
• Report Number: 1038671-2021-00697
• Device Sequence Number: 4291963
• Product Code: KWT
• UDI-Device Identifier: 10885862086402
• UDI-Public: 10885862086402
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2022

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 Model Number: 320-01-46
• Device Catalogue Number: 320-01-46
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2021
• Supplement Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White