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

Model Number	300-30-08
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon review of the available information, there is no evidence that this is a device related problem and there is no allegation against the device.Implantation of a total joint could result pain, infection, or fracture.The most likely cause of the reported event which was caused during implantation which was likely caused by applied pressure during implantation.Concomitant medical device(s): 320-36-03, 36mm humeral liner +2.5mm unconstrained; 320-10-05, equinoxe reverse tray adapter plate tray +5; 320-31-06, reverse glenosphere; 320-35-01, small glenoid plate.
Event or Problem Description
As reported, during the initial implantation of the right tsa in the (b)(6) y/o male patient, experienced a non-displaced humeral fracture of the greater tuberosity occurred.It was stable.No fixation required.The patient has a history of multiple shoulder arthroscopies and osteoarthritis.The case report form indicates this event is not related to devices and definitely related procedure.This event report was received through clinical data collection activities.

• Brand Name: EQUINOXE
• Common Device Name: PRESERVE STEM 8MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11373823
• Report Number: 1038671-2021-00072
• Device Sequence Number: 11447455
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/24/2021

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 86