MAUDE Adverse Event Report: ARTHREX, INC. 5.5X28MM PERIPHERAL SCREW, LOCKING; SHOULDR PROSTH, REVERSE CONFIG

Model Number	5.5X28MM PERIPHERAL SCREW, LOCKING
Medical Device Problem Code	Damaged Thread (4075)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 6/6/2024, it was reported by a sales representative via email that an ar-9563-28 univers revers modular glenoid system peripheral locking screw threading was a bit off and would not go all the way down into the 20-degree augment baseplate.A locking guide and a 3.0 drill bit were used.The screw was inserted with a hand driver, and when it got to the locking portion, it would not sit all the way.The case was completed using a new ar-9563-28 univers revers modular glenoid system peripheral locking screw.This was discovered during an rtsa procedure on (b)(6) 2024.
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: 5.5X28MM 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: 19684185
• Report Number: 1220246-2024-06607
• Device Sequence Number: 3175830
• Product Code: PHX
• UDI-Device Identifier: 00888867296862
• UDI-Public: 00888867296862
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2025

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: 5.5X28MM PERIPHERAL SCREW, LOCKING
• Device Catalogue Number: AR-9563-28
• Device Lot Number: 14964482
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 07/05/2024
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown