MAUDE Adverse Event Report: ARTHREX, INC. 5.5X20MM PERIPHERAL SCREW, LOCKING; SHOULDR PROSTH, REVERSE CONFIG

Model Number	5.5X20MM PERIPHERAL SCREW, LOCKING
Medical Device Problem Codes	Positioning Failure (1158); Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6)2025, a sales representative reported via phone that an ar-9563-20 univers revers modular glenoid system, peripheral screw had an issue.During a reverse total shoulder arthroplasty procedure on (b)(6)2025, when the surgeon was trying to use the screw, the screw would not lock into an ar-9580-2410s univers revers modular glenoid system augmented base plate inside the patient.The screw was removed from the patient in one piece, nothing broke, and there was no harm.Another ar-9563-20 univers revers modular glenoid system, peripheral screw with a different unknown lot number was screwed into the same ar-9580-2410s univers revers modular glenoid system augmented base plate inside the patient and the procedure was completed successfully.There was no complaint allegation against the base plate.The case was not delayed 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: d9, g3, h3, h6.Complaint allegation is not confirmed.One unpackaged ar-9563-20 was received for investigation.Upon visual inspection, it was noted that the threads of the 5.5x20mm peripheral screw, locking were damaged.Functional testing was not performed due to the damage to the device.The most likely cause of the reported failure can be attributed to user error due to excessive force used and/or misaligned insertion during use.Complaint allegation is not confirmed.

• Brand Name: 5.5X20MM 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: 21650797
• Report Number: 1220246-2025-01037
• Device Sequence Number: 9276464
• Product Code: PHX
• UDI-Device Identifier: 00888867296824
• UDI-Public: (01)00888867296824(11)240902(17)290831(10)15310354
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K173900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2025

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: 5.5X20MM PERIPHERAL SCREW, LOCKING
• Device Catalogue Number: AR-9563-20
• Device Lot Number: 15310354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2024
• 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