MAUDE Adverse Event Report: ARTHREX, INC. 24MM BASEPLATE, 10° FULL AUG, OB; SHOULDR PROSTH, REVERSE CONFIG

Model Number	24MM BASEPLATE, 10° FULL AUG, OB
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2024 , it was reported by a sales representative via email that an ar-9580-2410 univers revers modular glenoid system augmented baseplate and an ar-9582-20 modular post for augmented mgs baseplate would not engage with the taper.This was discovered during a procedure on (b)(6) 2024.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error due to misaligned insertion and/or improper bone preparation.

• Brand Name: 24MM BASEPLATE, 10° FULL AUG, OB
• Common Device Name: SHOULDR PROSTH, REVERSE CONFIG
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 21138062
• Report Number: 1220246-2025-09376
• Device Sequence Number: 6958083
• Product Code: PHX
• UDI-Device Identifier: 00888867341630
• UDI-Public: (01)00888867341630(11)240101(17)281231(10)1433812302
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K193372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 24MM BASEPLATE, 10° FULL AUG, OB
• Device Catalogue Number: AR-9580-2410
• Device Lot Number: 1433812302
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown