MAUDE Adverse Event Report: ARTHREX, INC. 24MM BASEPLATE, MODULAR; SHOULDR PROSTH, REVERSE CONFIG

Model Number	24MM BASEPLATE, MODULAR
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an inverse shoulder prosthesis surgery with mgs the thread of the glenosphere screw did not hold inside the base plate.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
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged ar-9560-24 univers revers¿ modular glenoid system modular baseplate 24 mm batch number: 15338548 was received for investigation.Visual evaluation of the returned device noted deep nicks and striations on the surface of the device.Visual inspection also noted damage to the threads of the device.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces when inserting the locking screw and/or misaligned insertion.

• Brand Name: 24MM BASEPLATE, 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: 21458697
• Report Number: 1220246-2025-00639
• Device Sequence Number: 7913098
• Product Code: PHX
• UDI-Device Identifier: 00888867296411
• UDI-Public: (01)00888867296411(11)241028(17)290930(10)15338548
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 04/30/2025

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, MODULAR
• Device Catalogue Number: AR-9560-24
• Device Lot Number: 15338548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2025
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2024
• 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