MAUDE Adverse Event Report: ARTHREX, INC. GLENOSPHERE SCREW; SHOULDR PROSTH, REVERSE CONFIG

Model Number	GLENOSPHERE SCREW
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6)2024 it was reported by a sales representative via (b)(4) that an ar-9565 glenosphere screw univers revers modular glenoid system tip broke off during insertion.No further information was provided.Additional information was received on 12/18/2024: the correct part number was ar-9625 3.0 mm hex driver, which had the tip break off during insertion.All fragments were retrieved from the patient.The case was completed using another ar-9625 3.0 mm hex driver.No case delay was reported, and no additional anesthesia was administered to the patient.This was discovered during an rtsa procedure on (b)(6)2024.Additional information was requested.
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 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: GLENOSPHERE SCREW
• 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: 21093312
• Report Number: 1220246-2025-09246
• Device Sequence Number: 13037957
• Product Code: PHX
• UDI-Device Identifier: 00888867296022
• UDI-Public: 00888867296022
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/10/2025

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: GLENOSPHERE SCREW
• Device Catalogue Number: AR-9565
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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