MAUDE Adverse Event Report: ARTHREX, INC. MODULAR POST, 35MM; SHOULDR PROSTH, REVERSE CONFIG

Model Number	MODULAR POST, 35MM
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 22-dec-2025, a sales representative reported via phone that an ar-9582-35 modular post for augmented mgs baseplate 35 mm experienced an issue with inserting a screw into the baseplate.This occurred during a reverse total shoulder replacement on (b)(6) 2025.This resulted in having to remove the ar-9582-35 and an ar-9580-2420-2.The case continued using another ar-9582-35 and another ar-9580-2420-2.There was no delay in the procedure.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Additional information was provided on 22-dec-2025 via e-mail where the sales representative reported that the patient's bone quality was not great.An augmented reamer was used to prepare the bone.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 the complaint device was not received for evaluation.Based on the information provided, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is a use error, including improper surgical technique associated with the device.Univers revers¿augmented modular glenoid system surgical technique implant assembly and insertion 12a baseplate assembly: combine the modular central post with the augmented modular baseplate component.These components mate via a taper connection.There is a hex feature that must be aligned between the components for the taper to engage.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 is facing up.The complaint allegation was not confirmed.No evidence of that failure was received.

• Brand Name: MODULAR POST, 35MM
• 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: 24035272
• Report Number: 1220246-2026-00121
• Device Sequence Number: 9010840
• Product Code: PHX
• UDI-Device Identifier: 00888867341869
• UDI-Public: (01)00888867341869(11)250801(17)300731(10)1867532508
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K193372
• 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,Followup
• Report Date (Section B): 04/20/2026

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: MODULAR POST, 35MM
• Device Catalogue Number: AR-9582-35
• Device Lot Number: 1867532508
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 12/22/2025; 04/17/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 01/16/2026; 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown