MAUDE Adverse Event Report: ARTHREX, INC. 4.5X24MM PERIPHERAL SCREW, NON-LOCKING; SHOULDR PROSTH, REVERSE CONFIG

Model Number	4.5X24MM PERIPHERAL SCREW, NON-LOCKING
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 7/9/2024, a clindex notification was received indicating that a patient listed on the shoulder arthroplasty registry underwent revision surgery for unknown reasons.Images were taken on (b)(6) 2024, showing the patient no longer had the original arthrex implants from the original surgery on (b)(6) 2022.Upon further review, it was discovered that the patient was revised on (b)(6) 2022 at an outside facility.An ar-9501-09s univers revers apex humeral stem size 9, an ar-9502f-36rcpc arthrex univers revers suture cup 36 mm, an ar-9582-20 modular post for augmented mgs baseplate 20 mm, an ar-9580-2420-2 univers revers modular glenoid system, augmented baseplate 24 mm +2, 20 degree full, two ar-9562-24nl univers revers modular glenoid system, peripheral screw, non-locking 4.5 x 24 mm, an ar-9503-3633-3c univers revers modular glenoid system constrained combo humeral insert 36 +3c / 33, an ar-9564-2433 arthrex univers revers modular glenoid system glenosphere 33/24, and two ar-9563-24 univers revers modular glenoid system, peripheral screw, locking 5.5 x 24 mm, were explanted during the revision surgery on (b)(6) 2022.No other information other than the date of surgery was available for review.Therefore, the reason for the revision and whether or not it was related to trauma is unknown.It is also unknown if the new implant system, implanted on (b)(6) 2022, are arthrex products.The patient is not experiencing pain with the implants; however, has a limited range of motion and strength.
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 a patient-specific event.

• Brand Name: 4.5X24MM PERIPHERAL SCREW, NON-LOCKING
• 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: 19829625
• Report Number: 1220246-2024-06913
• Device Sequence Number: 7421109
• Product Code: PHX
• UDI-Device Identifier: 00888867296671
• UDI-Public: 00888867296671
• 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
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Model Number: 4.5X24MM PERIPHERAL SCREW, NON-LOCKING
• Device Catalogue Number: AR-9562-24NL
• Device Lot Number: 2021002333
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2024
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2021
• 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