MAUDE Adverse Event Report: ARTHREX, INC. 24MM +2 LAT BASEPLATE, MODULAR; SHOULDR PROSTH, REVERSE CONFIG

Model Number	24MM +2 LAT BASEPLATE, MODULAR
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 06/20/2025, a sales representative reported via (b)(4) that an ar-9560-24-2 arthrex® univers revers¿ modular glenoid system modular baseplate was defective.This occurred in a reverse total shoulder arthroplasty procedure on (b)(6) 2025.The case was completed by opening a new baseplate and central screw (9560-24-2 and 9561-30s).Additional information was provided via phone on (b)(6) 2025 where the sales representative stated when putting the baseplate together with the screw and trying to put it on the inserter it was not catching.I t appeared not to be threaded after examining the device.There was a less than 5-minute delay during this procedure.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-9560-24-2, arthrex® univers revers¿ modular glenoid system modulas baseplate 24 mm +2 lat, batch number 15400885, was received for investigation.Visual inspection noted that the device had an ar-9561-30s stuck to it.Additionally, the center hole was noted to have a smooth surface.Per drawing (b)(4) rev 4, the center hole must be threaded.This is a known manufacturing issue.Refer to ncr-3082.The complaint allegation is confirmed.
Event or Problem Description
Additional information was provided by the sales representative via email that the allegation was noticed during step 8a from the reverse mgs technique guide.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.One unpackaged ar-9560-24-2, arthrex® univers revers¿ modular glenoid system modulas baseplate 24 mm +2 lat, batch number 15400885, was received for investigation.Visual inspection noted that the device had an ar-9561-30s stuck to it.Additionally, the center hole was noted to have a smooth surface.Per drawing c14373 rev 4, the center hole must be threaded.This is a known manufacturing issue addressed through a non-conformance.Refer to investigation photos.The complaint allegation is confirmed.

• Brand Name: 24MM +2 LAT BASEPLATE, 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: 22529947
• Report Number: 1220246-2025-02921
• Device Sequence Number: 7410216
• Product Code: PHX
• UDI-Device Identifier: 00888867296497
• UDI-Public: (01)00888867296497(11)250306(17)300228(10)15400885
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K173900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/10/2025

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: 24MM +2 LAT BASEPLATE, MODULAR
• Device Catalogue Number: AR-9560-24-2
• Device Lot Number: 15400885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 06/20/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2025
• Supplement Date Received by Manufacturer: 09/27/2025; 10/01/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 09/26/2025; 10/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown