MAUDE Adverse Event Report: ARTHREX, INC. 30MM CENTRAL SCREW, MODULAR; SHOULDR PROSTH, REVERSE CONFIG

Model Number	30MM CENTRAL SCREW, MODULAR
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a sales representative reported via phone that an ar-9560-24-4 univers revers modular glenoid system modulas baseplate and an ar-9561-30s univers revers modular glenoid system, central screw, had an issue during a reverse total shoulder arthroplasty procedure on (b)(6) 2025.When the surgeon was screwing the central screw into the glenoid, the central screw detached on the last turn from the baseplate and was stuck in the patient's bone.The screw did not break and was removed from the patient's bone in one piece, and the baseplate was also removed.Nothing broke inside the patient, and there was no harm to the patient.Another ar-9560-24-4 univers revers modular glenoid system modulas baseplate and an ar-9561-30s univers revers modular glenoid system, central screw, with different unknown lot numbers, were used to complete the procedure successfully.There was a case delay of under 15 minutes, 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 confirmed.One unpackaged ar-9561-30s univers revers¿ modular glenoid system, modular 30 mm central screw was received for investigation.Visual evaluation of the returned device noted that the internal hex where the baseplate connects was damaged.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces when assembling the mating devices.

• Brand Name: 30MM CENTRAL SCREW, MODULAR
• 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: 21376818
• Report Number: 1220246-2025-00445
• Device Sequence Number: 8432084
• Product Code: PHX
• UDI-Device Identifier: 00888867296572
• UDI-Public: (01)00888867296572(11)240912(17)290831(10)15316692
• 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: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2025

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: 30MM CENTRAL SCREW, MODULAR
• Device Catalogue Number: AR-9561-30S
• Device Lot Number: 15316692
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2024
• 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