MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; PRESERVE STEM 6MM

Model Number	300-30-06
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant device: 320-36-10 - 36mm humeral liner +0mm constrained; 320-10-00 - equinoxe reverse tray adapter plate tray +0; 320-35-07 - small superior/posterior aug glenoid plate,left; 320-31-36 - glenosphere, 36mm.
Event or Problem Description
As reported by the equinoxe shoulder study, this (b)(6) female patient experienced a humeral fracture.Cortical split was treated with cables.The case report form indicates this event is definitely related to devices and procedure.This event report was received through clinical data collection activities.
Event or Problem Description
As reported by the equinoxe shoulder study, this 77 y/o female patient at 250 lbs., experienced a mid-shaft humeral fracture intraoperatively, the surgeon managed this cortical split using cables.During the procedure, the patient had an autograft from the humeral head; the bone graft comments state that there was ¿a split about the anterior medial cortex was grafted¿.The patient also had a bicep tenodesis during this procedure.The preoperative diagnosis for this patient was a proximal humerus fracture.The case report form indicates this event is definitely related to devices and procedure.This event report was received through clinical data collection activities.No additional information.
Additional Manufacturer Narrative
(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 cause of the surgical event cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition of a pre-surgical diagnosis of humeral fracture and comorbidities.Section h11: the following sections have corrected information: (b5) describe event or problem: as reported by the equinoxe shoulder study, this 77 y/o female patient at 250 lbs., experienced a mid-shaft humeral fracture intraoperatively, the surgeon managed this cortical split using cables.During the procedure, the patient had an autograft from the humeral head; the bone graft comments state that there was ¿a split about the anterior medial cortex was grafted¿.The patient also had a bicep tenodesis during this procedure.The preoperative diagnosis for this patient was a proximal humerus fracture.The case report form indicates this event is definitely related to devices and procedure.This event report was received through clinical data collection activities.No additional information.

• Brand Name: EQUINOXE
• Common Device Name: PRESERVE STEM 6MM
• 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: 14521136
• Report Number: 1038671-2022-00623
• Device Sequence Number: 6551717
• Product Code: KWT
• UDI-Device Identifier: 10885862515742
• UDI-Public: 10885862515742
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K162726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2022

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: 300-30-06
• Device Catalogue Number: 300-30-06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2022
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 05/27/2022
• Supplement Report FDA Received Date: 08/31/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 114 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White