MAUDE Adverse Event Report: ARTHREX, INC. 35MM CENTRAL SCREW, MODULAR; SHOULDR PROSTH, REVERSE CONFIG

Model Number	35MM CENTRAL SCREW, MODULAR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
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 (b)(6) 2025, it was reported by a sales representative via phone that an ar-9560-24-2 arthrex univers revers modular glenoid system modulas baseplate and an ar-9561-35s univers revers modular glenoid system central screw fell apart once implanted.The surgeon used a screwdriver to remove the implants from the patient.The case was completed using a new baseplate and central screw.This was discovered during a revers shoulder procedure on (b)(6) 2025.The patient was not affected.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-9561-35s, 35mm central screw serial/batch number (b)(6), was received for investigation.A visual evaluation found damage and deformation in the internal hex connector hole.Functional testing was not conducted to avoid damage to the well-known mating part.Functional testing with the returned ar-9560-24-2 cannot be performed as the internal hex of the 35mm central screw was deformed.The most likely cause of the reported failure is user error, specifically, failure to achieve the appropriate torque requirements when tightening the central screw directions for use dfu-0189 univers revers¿ shoulder prosthesis system e.Warnings.8.Failure to achieve the appropriate torque requirements when tightening locking screws may result in the premature loosening of the device.22.Proper anchoring is of decisive importance for firm, permanent positioning of the prosthesis.

• Brand Name: 35MM 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: 21434730
• Report Number: 1220246-2025-00595
• Device Sequence Number: 19984992
• Product Code: PHX
• UDI-Device Identifier: 00888867296589
• UDI-Public: (01)00888867296589(11)200801(17)250731(10)8765
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/27/2025

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 Expiration Date: 07/31/2025
• Device Model Number: 35MM CENTRAL SCREW, MODULAR
• Device Catalogue Number: AR-9561-35S
• Device Lot Number: 8765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2020
• 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
• Patient Sex: Unknown