MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE PRESERVE STEM 10MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	EQUINOXE PRESERVE STEM 10MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Periprosthetic fracture (4902)
Date of Event	06/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a female patient, who was undergoing an initial shoulder implant surgery, was found to have a humerus fracture.During the procedure, the surgeon had placed the cut guide against the humerus and resected the humeral head.He then began to ream the humerus working through the reamers.The patient has an exactech total shoulder on the contralateral side and had a 15 stem in which is what the surgeon was targeting, he reached the 15 reamer and was just finishing reaming, when he felt something on the humerus, so he stopped reaming and had xray come in.They took an image, and the doctor noticed a fracture approx.20-30 mm below the top of the reamer.He exposed the fracture and decided the best plan of action was to close the wound and address the fracture the next day when the proper plates and equipment were available.He also contacted his trauma partner and scheduled him to help in the repair of the fracture.On (b)(6) 2023 the case began with both surgeon¿s addressing the fracture with a small frag plate.The fracture reduced nicely, and the surgeon also added on a longer proximal humerus plate with screws and a kinked super cable proximally.Once the fracture was repaired the surgeon completed the reverse shoulder utilizing a preserve stem cemented in the humerus and plate screws.The glenoid was repaired and a 38 glenosphere was implanted with standard glenoid plate.They then trialed the tray and liner and found that the 38 +0 liner and +0 tray was the correct size and implanted the final implants.The shoulder was reduced and then closed.There were no device breakages or delays reported.The patient was last known to be in stable condition following the event.No device returns anticipated as nothing happened with the implants.No further information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the intraoperative bone fracture reported cannot be conclusively determined but may be related to a patient condition or high forces during broaching, reaming, exposure, or retraction.However, this cannot be confirmed based on the information provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE PRESERVE STEM 10MM
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17336821
• Report Number: 1038671-2023-01682
• Device Sequence Number: 6607961
• Product Code: PHX
• UDI-Device Identifier: 10885862515780
• UDI-Public: 10885862515780
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K162726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

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: EQUINOXE PRESERVE STEM 10MM
• Device Catalogue Number: 300-30-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2023
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2019
• 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
• Patient Sex: Female