MAUDE Adverse Event Report: ARTHREX, INC. 42 +4 LAT/24 GLENOSPHERE; SHOULDR PROSTH, REVERSE CONFIG

Model Number	42 +4 LAT/24 GLENOSPHERE
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/23/2023
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via email that an ar-9564-2442-lat arthrexunivers revers modular glenoid system glenosphere would spin around the baseplate when the screw was attempting to be torqued.This was discovered during a revision reverse total shoulder procedure on (b)(6) 2023.A new glenosphere was used to complete the case.
Additional Manufacturer Narrative
The complaint allegation is confirmed.Based on the images supplied from the field, it is evident that the device has striation marks inside the device.Consequently, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user-applied excessive force while over-torquing/over-engaging the device during use.

• Brand Name: 42 +4 LAT/24 GLENOSPHERE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16785318
• Report Number: 1220246-2023-06569
• Device Sequence Number: 12182197
• Product Code: PHX
• UDI-Device Identifier: 00888867295742
• UDI-Public: 00888867295742
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K173900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: 42 +4 LAT/24 GLENOSPHERE
• Device Catalogue Number: AR-9564-2442-LAT
• Device Lot Number: 19.02954
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2023
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown