MAUDE Adverse Event Report: ARTHREX, INC. UNI GLENOID-PERIPHERAL LOCK SCRW; SHOULDR PROSTH, REVERSE CONFIG

Model Number	UNI GLENOID-PERIPHERAL LOCK SCRW
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/15/2024, it was reported by a sales representative via phone that an ar-9145-36 arthrex universal glenoid peripheral locking screw 36 mm had an issue during a reverse total shoulder arthroplasty on (b)(6) 2024.When the surgeon was trying to lock the screw into an ar-9120-01pc revers glenoid porous coat baseplate, s, he felt the screw was not locking down correctly.He backed out the screw, re-screwed it, and felt it was down enough and affixed correctly to use it.The screw remained inside the patient, and no pictures were taken.The surgeon felt the screw was not biting correctly into the baseplate and wanted to report the complaint.There was no issue observed with the base plate.The procedure was completed successfully with no harm to the patient.There was no case delay, and no additional anesthesia was administered.This occurred during use with no reported patient harm.
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: UNI GLENOID-PERIPHERAL LOCK SCRW
• 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: 20543742
• Report Number: 1220246-2024-08275
• Device Sequence Number: 15260197
• Product Code: PHX
• UDI-Device Identifier: 00888867057739
• UDI-Public: (01)00888867057739(11)240301(17)290228(10)23.05074
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K142863
• 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): 07/08/2025

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: UNI GLENOID-PERIPHERAL LOCK SCRW
• Device Catalogue Number: AR-9145-36
• Device Lot Number: 23.05074
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2024
• 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