MAUDE Adverse Event Report: EXACTECH, INC. SMALL SUPERIOR/POSTERIOR AUG GLENOID PLATE, RIGHT; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	320-35-08
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Limb Fracture (4518)
Date of Event	11/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the equinoxe shoulder study that this 77 y/o female patient experienced an intra-op coracoid fracture with reduction and had a removal of a gps tracker.The case report form indicates this event is definitely related to devices or procedure.This event report was received through clinical data collection activities.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation (d10) concomitant device(s): 320-36-03 - 145-deg pe 36mm hum liner +2.5: (b)(6).320-10-00 - equinoxe reverse tray adapter plate tray +0: (b)(6).320-31-36 - glenosphere, 36mm: (b)(6).320-35-08 - small superior/posterior augglenoid plate,right: (b)(6).315-35-00 - glnd kwire: (b)(6).315-35-00 - glnd kwire: (b)(6).320-15-05 - eq rev locking screw: (b)(6).320-20-00 - eq reverse torque defining screw kit: (b)(6).320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm: (b)(6).320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm, (b)(6).320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm, (b)(6).320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm, (b)(6).521-78-31 - threaded pin size 2.6 collarless 2pk, (b)(6).
Additional Manufacturer Narrative
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.D1: corrected d2: corrected d3: corrected d4: corrected g4: corrected h4: corrected h6: corrected health effect, medical device, component, and investigation clinical codes.

• Brand Name: SMALL SUPERIOR/POSTERIOR AUG GLENOID PLATE, RIGHT
• 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18435366
• Report Number: 1038671-2024-00008
• Device Sequence Number: 7661112
• Product Code: PHX
• UDI-Device Identifier: 10885862534927
• UDI-Public: 10885862534927
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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 Catalogue Number: 320-35-08
• 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: 12/14/2023
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2023
• 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.
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White