MAUDE Adverse Event Report: ARTHREX, INC. 24MM BASEPLATE, 10° FULL AUG, +2 LAT, ST; SHOULDR PROSTH, REVERSE CONFIG

Model Number	24MM BASEPLATE, 10° FULL AUG, +2 LAT, ST
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/17/2024
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 (b)(6)2024, a sales representative reported via email that a compressor made an abnormally loud creaking noise when the ar-9582-25 modular post for augmented mgs baseplate 25 mm and ar-9580-2410-2s univers revers modular glenoid system augmented base plate 24 mm+2 was placed together.The post and baseplate did not disengage.However, a new baseplate and post were used to complete the case and avoid complications.This was discovered during a reverse total shoulder replacement procedure on (b)(6)2024.Nothing broke in the patient.The case was only delayed for about five minutes with additional anesthesia.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed.Due to photographic evidence provided from the field of an ar-9580-2410-2s, with batch number 1356662235, arthrex was able to conclude a most likely cause.The most likely cause of the reported failure is wear and tear.Due to continuous mechanical forces applied to it, the device will inevitably sustain damage over time.

• Brand Name: 24MM BASEPLATE, 10° FULL AUG, +2 LAT, ST
• 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: 20031435
• Report Number: 1220246-2024-07226
• Device Sequence Number: 16902810
• Product Code: PHX
• UDI-Device Identifier: 00888867352100
• UDI-Public: 00888867352100
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K211074
• 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): 06/27/2025

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, 10° FULL AUG, +2 LAT, ST
• Device Catalogue Number: AR-9580-2410-2S
• Device Lot Number: 1356662235
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2024
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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