MAUDE Adverse Event Report: ARTHREX, INC. 25MM CENTRAL SCREW, MODULAR; SHOULDR PROSTH, REVERSE CONFIG

Model Number	25MM 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	10/31/2025
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
It was reported that during a revers shoulder arthroplasty on insertion, using the cannulated inserter, the baseplate detached from the post and the post remained in the glenoid vault.The initial implant assembly was observed by the rep and seemed to be as per instructions.Baseplate & post seemed to be aligned and full compression was achieved using the device.It was successfully removed using a 4mm hex and a new baseplate & post were assembled and inserted successfully.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-9561-25s (25 mm central screw), batch number 15416317, was received for investigation.Visual inspection revealed surface damage within the cannulated shaft.Functional testing was not performed due to the observed damage to the device.Most likely cause: a use-related assembly issue involving incomplete mechanical engagement or locking of the baseplate-to-post interface during assembly.Refer to the investigation photographs for documentation of findings.Based on the evaluation results, the complaint allegation is confirmed.

• Brand Name: 25MM 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: 23681164
• Report Number: 1220246-2025-05265
• Device Sequence Number: 15891281
• Product Code: PHX
• UDI-Device Identifier: 00888867296565
• UDI-Public: (01)00888867296565(11)250407(17)300331(10)15416317
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K173900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2026

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: 25MM CENTRAL SCREW, MODULAR
• Device Catalogue Number: AR-9561-25S
• Device Lot Number: 15416317
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2025
• 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