MAUDE Adverse Event Report: ARTHREX, INC. 24MM BASEPLATE, 20° FULL AUG, ST; SHOULDR PROSTH, REVERSE CONFIG

Model Number	24MM BASEPLATE, 20° FULL AUG, ST
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
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 08/29/2025, a sales representative reported via email that an ar-9580-2420s univers revers modular glenoid system augmented base plate (24 mm) and the ar-9675-s angled reamer did not function properly during a procedure.The patient was not impacted, as replacement devices of the same models were used successfully.This was discovered during a procedure on (b)(6) 2025, with no reported patient harm.Additional information has been requested on 09/05/2025.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided, which may include the returned device (if available), photographs, videos, event description, and any additional field input, arthrex has determined the most likely cause.The most likely cause is attributed to a use-related factor, such as: improper assembly or setup of the modular glenoid system components, incorrect engagement or alignment of the angled reamer.

• Brand Name: 24MM BASEPLATE, 20° FULL AUG, ST
• 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: 23098837
• Report Number: 1220246-2025-03968
• Device Sequence Number: 8572783
• Product Code: PHX
• UDI-Device Identifier: 00888867352063
• UDI-Public: (01)00888867352063(11)231201(17)281130(10)1401952247
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K211074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

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, 20° FULL AUG, ST
• Device Catalogue Number: AR-9580-2420S
• Device Lot Number: 1401952247
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 08/29/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown