MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL INSERT S/36 +3 TO FIT IN 36 CUP; SHOULDR PROSTH, REVERSE CONFIG

Model Number	HUMERAL INSERT S/36 +3 TO FIT IN 36 CUP
Medical Device Problem Codes	Use of Device Problem (1670); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/04/2025, it was reported by an arthrex subsidiary employee via (b)(4) that when an ar-9503s-03 humeral insert hit the cup, it got damaged and would not hook into the cup.This was discovered during use with no patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
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 user-related factors, misuse/mishandling, causing damage to the humeral insert due to impact force when the ar-9503s-03 humeral insert struck the cup.

• Brand Name: HUMERAL INSERT S/36 +3 TO FIT IN 36 CUP
• 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: 23881605
• Report Number: 1220246-2025-05786
• Device Sequence Number: 4706916
• Product Code: PHX
• UDI-Device Identifier: 00888867061293
• UDI-Public: 00888867061293
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K142863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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: HUMERAL INSERT S/36 +3 TO FIT IN 36 CUP
• Device Catalogue Number: AR-9503S-03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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