MAUDE Adverse Event Report: ARTHREX, INC. 25MM CENTRAL POST, MODULAR; SHOULDR PROSTH, REVERSE CONFIG

Model Number	25MM CENTRAL POST, MODULAR
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via phone that an ar-9561-25p univers revers modular glenoid system, central post, modular 25 mm was not connecting to the glenoid base plate connection.The case was completed opening another ar-9561-25p with no reported delay in the procedure or additional anesthesia administered.No fragments broke inside the patient.This was discovered during a reverse total shoulder procedure on (b)(6) 2023, with no adverse event or patient harm.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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 of the device due to misaligned insertion and/or not using glenosphere forceps.Per the precautions of the dfu for this device: 25.Thoroughly clean and dry tapers, prior to attachment of modular components to avoid crevice corrosion and improper seating.Glenosphere forceps are required to verify integrity of the morse taper connection between glenosphere and baseplate.

• Brand Name: 25MM CENTRAL POST, MODULAR
• 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: emily shafer ; 8009337001
• MDR Report Key: 18049050
• Report Number: 1220246-2023-08503
• Device Sequence Number: 8076574
• Product Code: PHX
• UDI-Device Identifier: 00888867296527
• UDI-Public: 00888867296527
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K173900
• 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): 03/11/2025

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: 25MM CENTRAL POST, MODULAR
• Device Catalogue Number: AR-9561-25P
• Device Lot Number: 15047267
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2023
• Supplement Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2023
• 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
• Patient Sex: Unknown