MAUDE Adverse Event Report: ARTHREX, INC. 42+6 / 45 COMBINATION HUMERAL INSERT; SHOULDR PROSTH, REVERSE CONFIG

Model Number	42+6 / 45 COMBINATION HUMERAL INSERT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 5/13/2024, it was reported by a sales representative via (b)(4) that an ar-9503-4245-6 univers revers modular glenoid system, combo humeral insert trial chipped in the case.The case was completed successfully without further action, and no reported pieces broke in the patient.This was discovered during an rtsa procedure on (b)(6) 2024, with no reported patient harm.Additional information was received on 5/21/2024: there was no case delay.
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 improper bone preparation and/or prying/leveraging during use.

• Brand Name: 42+6 / 45 COMBINATION HUMERAL INSERT
• 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: 19497931
• Report Number: 1220246-2024-05369
• Device Sequence Number: 15116602
• Product Code: PHX
• UDI-Device Identifier: 00888867308916
• UDI-Public: 00888867308916
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K191960
• 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): 06/30/2025

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: 42+6 / 45 COMBINATION HUMERAL INSERT
• Device Catalogue Number: AR-9503-4245-6
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2024
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 06/30/2025
• 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