MAUDE Adverse Event Report: EXACTECH, INC. SMALL SUPERIOR AUGMENT GLENOID PLATE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	320-35-02
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Limb Fracture (4518)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant device(s): 320-40-00 - 145-deg pe 40mm hum liner +0; (b)(6).300-01-13 - equinoxe, humeral stem primary, press fit 13mm; (b)(6).320-10-00 - equinoxe reverse tray adapter plate tray +0; (b)(6).320-31-40 - glenosphere, 40mm; (b)(6).320-35-02 - small superior augment glenoid plate; (b)(6).320-15-05 - eq rev locking screw; (b)(6).320-20-00 - eq reverse torque defining screw kit; (b)(6).320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm; (b)(6).320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm; (b)(6).320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm; (b)(6).321-52-10 - 3.2mm k-wire, thd, short 2 k-wires per pack; (b)(6).531-55-88 - ergo gps 3.2mm drill kit sterile; (b)(6).531-78-20 - shouldr gps hex pins kit; (b)(6).
Event or Problem Description
Approximately 10 months after initial rtsa, the patient experienced a coracoid scapular fracture.The event is reported to be possible related to the procedure and unlikely related to the device.No action was taken (awaiting additional test results).The outcome is continuing.The implants remain implanted.
Additional Manufacturer Narrative
The reason for the post operative coracoid scapular bone fracture reported cannot be conclusively determined but may be related to implant positioning, patient bone quality, a trauma, and/or another patient related condition.However, this cannot be confirmed based on the information provided.D1: corrected.D4: corrected.D10: concomitant devices 320-40-00 - 145-deg pe 40mm hum liner +0 (b)(6), 300-01-13 - equinoxe, humeral stem primary, press fit 13mm (b)(6), 320-10-00 - equinoxe reverse tray adapter plate tray +0 (b)(6), 320-31-40 - glenosphere, 40mm (b)(6), 320-15-05 - eq rev locking screw (b)(6), 320-20-00 - eq reverse torque defining screw kit (b)(6), 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm (b)(6), 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm (b)(6), 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm (b)(6), 321-52-10 - 3.2mm k-wire, thd, short 2 k-wires per pack (b)(6), 531-55-88 - ergo gps 3.2mm drill kit sterile (b)(6), 531-78-20 - shouldr gps hex pins kit (b)(6).G4: k180632 k182536.H4: corrected.H6: corrected health effect, component, and investigation clinical codes.

• Brand Name: SMALL SUPERIOR AUGMENT GLENOID PLATE
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19706037
• Report Number: 1038671-2024-02333
• Device Sequence Number: 18080430
• Product Code: PHX
• UDI-Device Identifier: 10885862534873
• UDI-Public: 10885862534873
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H11
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

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: 320-35-02
• 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: 07/01/2024
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 07/25/2025
• Date Device Manufactured: 06/29/2021
• 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 H11
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White