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

Model Number	24MM BASEPLATE, MODULAR
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
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 06/17/2025, a sales representative reported via phone that an ar-9560-24 arthrex® univers revers¿ modular glenoid system modulas baseplate 24 mm and an ar-9561-25s univers revers¿ modular glenoid system central screw came apart from each other.This occurred during a reverse total shoulder procedure the two devices mate together as always and during implantation the screw completely disassociated from the plate.All the fragments were retrieved.An the case was completed using another ar-9560-24 arthrex® univers revers¿ modular glenoid system modulas baseplate 24 mm and an ar-9561-25s univers revers¿ modular glenoid system central screw.This delayed the procedure 3-4 minutes, where minimal additional anesthesia was required.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.- one unpackaged ar-9560-24-2 24mm +2 lat baseplate, modular serial/batch number (b)(6), was received for investigation.- visual evaluation noted damage to the threads of the baseplate connector.Additionally, an ar-9561-25s: univers revers¿ modular glenoid system central screw was stuck to it.- functional testing was not performed due to the damage to the device.- the most likely cause for the reported failure can be attributed to use error due to misalignment and/or not using a taper press.- per the surgical technique, lt1-00112-en_j, outlines in the following under the steps for modular baseplate assembly: there is a hex tip that must be aligned between the components in order for the taper to engage (see illustration).Rotate the components until the hex features align, resulting in a tactile coupling.Place the joined components within the taper assembly stand so that the central post/screw is facing up.Note: use the taper press to ensure proper taper connection between components.- the complaint allegation that the central screw disassociated from the baseplate during implantation cannot be confirmed as they were returned mated together.- refer to the investigation photos.

• Brand Name: 24MM 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: 22485151
• Report Number: 1220246-2025-02839
• Device Sequence Number: 8040564
• Product Code: PHX
• UDI-Device Identifier: 00888867296411
• UDI-Public: (01)00888867296411(11)250107(17)291231(10)15369747
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2025

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 BASEPLATE, MODULAR
• Device Catalogue Number: AR-9560-24
• Device Lot Number: 15369747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 06/17/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown