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

Model Number	24MM BASEPLATE, 10° FULL AUG, ST
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
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 (b)(6) 2025, a sales representative reported via phone that an ar-9563-16 peripheral locking screw did not lock into an ar-9580-2410s 24mm base plate during a reverse shoulder arthroplasty procedure on (b)(6) 2025.The issue was resolved by using two replacement ar-9563-20 peripheral locking screws (5.5 x 20 mm) to complete the case.There was no delay, no additional anesthesia, and no reported patient harm.
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 misalignment of the screw insertion and/or improper surgical technique associated with the device.The complaint allegation was not confirmed.Evaluation of the ar-9563-16 peripheral locking screw (batch 15385060) identified no issues.The ar-9580-2410s (batch 1643892347) was used in conjunction with other screws.

• Brand Name: 24MM BASEPLATE, 10° FULL AUG, 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: 24035721
• Report Number: 1220246-2026-00131
• Device Sequence Number: 9260005
• Product Code: PHX
• UDI-Device Identifier: 00888867352056
• UDI-Public: (01)00888867352056(11)240901(17)290831(10)1643892347
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 04/28/2026

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: 24MM BASEPLATE, 10° FULL AUG, ST
• Device Catalogue Number: AR-9580-2410S
• Device Lot Number: 1643892347
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/19/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown