MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; 6.5MM PLATFORM FX STEM RIGHT

Model Number	304-22-07
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/08/2021
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, during the initial rtsa on this (b)(6) female, as the surgeon were impacting the stem, they noticed the lesser tuberosity fragment had fractured.They were then able to impact the stem into position.The surgeon noted there is no extension of the fracture down the humeral canal.A fiber-wire cerclage tape was placed just distal to where the fracture line was to prevent any further propagation during final implantation.This patient has known osteogenesis imperfecta.The case report form indicates this event is unlikely related to devices and possibly related to the 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: 6.5MM PLATFORM FX STEM RIGHT
• 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: 12141936
• Report Number: 1038671-2021-00333
• Device Sequence Number: 4752348
• Product Code: KWT
• UDI-Device Identifier: 10885862083388
• UDI-Public: 10885862083388
• Combination Product (Y/N): N
• PMA/510(K) Number: K092900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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: 304-22-07
• Device Catalogue Number: 304-22-07
• 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: 06/22/2021
• Supplement Date Received by Manufacturer: 10/31/2021
• Initial Report FDA Received Date: 07/09/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 43 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White