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	03/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, during stem impaction in a l total shoulder procedure on a (b)(6) female patient, there was a calcar fracture to the l shoulder.It was repaired with a cerclage and the procedure was completed.The patient has a history of osteoarthritis.There is no device to be returned.The case report form indicates this event is possibly related to devices and/or possibly related to procedure.This event report was received through clinical data collection activities.
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 310-01-41 - equinoxe, humeral head short, 41mm (alpha), 300-10-45 - equinoxe replicator plate 4.5mm o/s, and 314-13-02 - equinoxe cage glenoid small, alpha.
Additional Manufacturer Narrative
Section h10: (h3) the calcar fracture was reported to have occurred during the implant implementation.It likely occurred while preparing the shoulder for and may have been related to the feed rate/pressure of the calcar planer, reamer rotational speed, or the patient¿s bone quality/geometry.

• 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: 14082980
• Report Number: 1038671-2022-00414
• Device Sequence Number: 11296524
• Product Code: KWT
• UDI-Device Identifier: 10885862515742
• UDI-Public: 10885862515742
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2022

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: 03/23/2022
• Supplement Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 05/10/2022
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White