MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; PRESERVE STEM 8MM

Model Number	300-30-08
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation: concomitant device(s): 320-36-00, 36mm humeral liner +0 unconstrained.320-10-00, equinoxe reverse tray adapter plate tray +0.320-31-36, glenosphere, 36mm.320-35-01, small glenoid plate.
Event or Problem Description
As reported, the patient suffered a (b)(6) female patient experienced a scapular spine fracture.The patient felt a painful pop in rt shoulder and has not seen improvement with conservative management.Open reduction internal fixation of the scapular spine.Outcome is noted as resolved (b)(6) 2021 in the study database.The case report form indicates this event is definitely related to devices or procedure.This event report was received through clinical data collection activities.
Additional Manufacturer Narrative
Section h10: (h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The most likely cause of the reported event was a fracture which was likely caused during implantation of the shoulder.

• Brand Name: EQUINOXE
• Common Device Name: PRESERVE STEM 8MM
• 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: 12251955
• Report Number: 1038671-2021-00365
• Device Sequence Number: 4742915
• Product Code: KWT
• UDI-Device Identifier: 10885862515766
• UDI-Public: 10885862515766
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2021

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: 300-30-08
• Device Catalogue Number: 300-30-08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/12/2021
• Supplement Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 07/30/2021
• Supplement Report FDA Received Date: 11/21/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American