MAUDE Adverse Event Report: ARTHREX, INC. 5.5X36MM PERIPHERAL SCREW, LOCKING; SHOULDR PROSTH, REVERSE CONFIG

Model Number	5.5X36MM PERIPHERAL SCREW, LOCKING
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On 07/25/2025, a sales representative reported via email that the ar-9580-2420-2s univers revers modular glenoid system augmented baseplate (24 mm) had failed, necessitating a revision procedure.The issue originated during a reverse shoulder arthroplasty performed on (b)(6) 2025.To address the failure, the surgical team successfully removed the ar-9580-2420-2s baseplate (24 mm), ar-9582-30 modular post for augmented mgs baseplate 30 mm, ar-9563-24 peripheral locking screw, and ar-9563-36 peripheral locking screw.They proceeded with the implantation of a non-arthrex small screw baseplate, which was supplemented by bone grafting.A new arthrex cup and polyethylene liner were also placed.The revision surgery was completed without further complications.Additional information has been requested on 07/31/2025.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
On november 26, 2025, the mentor failure analysis lab received the device for evaluation.On november 26, 2025, mentor received additional information that indicated that the patient actually underwent surgical intervention (mastopexy) on the left breast in 2021 for asymmetry and also had lumpectomy and radiation on the right breast due to significant encapsulation and contracture.On november 26, 2025, the product investigation was completed.Device investigation summary: the product was returned to mentor for evaluation.Mentor then conducted visual inspection and microscopic examination of the returned device.Visual analysis of the returned device determined that the breast implant was found to be ruptured and received in two parts.Microscopic examination was performed on the edges of the rupture, and parallel striations were found in an area of the tear on the anterior view, measuring less than 0.1 cm.Parallel striations are consistent with markings made by a sharp object perforating the implant shell.The cause of the rupture in the remaining area of the tear could not be identified.Mentor also performed a manufacturing record evaluation related to the reported complaint for the finished device lot number.No manufacturing non-conformances were identified as part of this evaluation.As part of mentor's quality process, all devices are manufactured, inspected, and released according to approved specifications.Based on the results of this investigation, it was determined that the product met the manufacturing release criteria: no corrective and preventive action (capa) is required now.This medwatch form is for the left breast prosthesis.The complication and surgical intervention on the right breast will be reported under mrn: (b)(6).

• Brand Name: 5.5X36MM PERIPHERAL SCREW, 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: 22792977
• Report Number: 1220246-2025-03455
• Device Sequence Number: 18303572
• Product Code: PHX
• UDI-Device Identifier: 00888867296909
• UDI-Public: (01)00888867296909(11)240523(17)290430(10)15253156
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 12/12/2025

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 Model Number: 5.5X36MM PERIPHERAL SCREW, LOCKING
• Device Catalogue Number: AR-9563-36
• Device Lot Number: 15253156
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/25/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown