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

Model Number	25MM CENTRAL SCREW, MODULAR
Medical Device Problem Codes	Defective Device (2588); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2024
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 9/17/2024, it was reported by a sales representative via email that an ar-9561-25s univers revers modular central screw and an ar-9560-24-2 arthrex univers revers modulas baseplate failed.This was discovered during a procedure on (b)(6) 2024.
Event or Problem Description
Additional information received on 9/20/2024: this was discovered during an rtsa procedure.The sales representative reported that the surgeon attempted to screw in the baseplate when the morse taper came apart, and the central screw fell off the baseplate.All products were retrieved.The case was completed using a new ar-9561-25s univers revers modular central screw and an ar-9560-24-2 arthrex univers revers modulas baseplate.The case was not delayed, and additional anesthesia was not needed.
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 due to misaligned insertion and/or improper bone preparation.

• Brand Name: 25MM CENTRAL SCREW, 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: jared engle ; 8009337001
• MDR Report Key: 20300904
• Report Number: 1220246-2024-07837
• Device Sequence Number: 12957728
• Product Code: PHX
• UDI-Device Identifier: 00888867296565
• UDI-Public: (01)00888867296565(11)240131(17)281231(10)15201131
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 07/07/2025

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 SCREW, MODULAR
• Device Catalogue Number: AR-9561-25S
• Device Lot Number: 15201131
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: 09/20/2024; 06/10/2025
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 10/01/2024; 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2024
• 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