MAUDE Adverse Event Report: ARTHREX, INC. 33 +4 LAT/24 GLENOSPHERE; SHOULDR PROSTH, REVERSE CONFIG

Model Number	33 +4 LAT/24 GLENOSPHERE
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/15/2025
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, it was reported by a sales representative via email that a glenosphere screw would not lock into an ar-9564-2433-lat arthrex univers revers glenosphere, even after being countersunk.A new glenosphere screw was opened, but it also failed to lock, indicating a possible issue with the threads on the glenosphere.The faulty glenosphere was removed, and a new glenosphere was inserted, which functioned properly and allowed the procedure to be completed successfully.This was discovered during a procedure on (b)(6) 2025.Additional information was received on 18-dec-2025: during an rtsa procedure, the screw that came packaged with the glenosphere failed to lock while the glenosphere was already implanted in the patient.A new screw, individually packaged as an ar-9565 glenosphere screw, was opened; however, this screw also failed.The original glenosphere was removed, and the case was completed using a completely new glenosphere along with the screw that is packaged with that glenosphere.Nothing broke inside the patient, and no fragments were left behind.The surgery experienced an approximate five-minute delay, and no additional anesthesia was administered.
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 manufacturing issue with the thread of the ar-9564-2433-la, leading to difficulty engaging the screws.The complaint allegation was not confirmed.No evidence of that failure was received.

• Brand Name: 33 +4 LAT/24 GLENOSPHERE
• 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: 23955831
• Report Number: 1220246-2026-00027
• Device Sequence Number: 20236808
• Product Code: PHX
• UDI-Device Identifier: 00888867295650
• UDI-Public: (01)00888867295650(11)250501(17)300430(10)10062
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K173900
• 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): 04/15/2026

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: 33 +4 LAT/24 GLENOSPHERE
• Device Catalogue Number: AR-9564-2433-LAT
• Device Lot Number: 10062
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2025
• 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