MAUDE Adverse Event Report: ARTHREX, INC. 20MM CENTRAL SCREW, MODULAR; SHOULDR PROSTH, REVERSE CONFIG

Model Number	20MM CENTRAL SCREW, 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
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
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
Additional information: the complaint allegation is not confirmed as the reported failure is for the returned mating ar-9560-24 univers revers¿ modular glenoid system modular baseplate 24 mm batch number: 15338548 (b)(4) not threading with the unreturned glenosphere screw with unknown part number (b)(4).Refer to record cross references.One unpackaged ar-9561-20s modular 20 mm central screw was received for investigation.The device was received assembled to the device for (b)(4), an ar-9560-24 univers revers¿ modular glenoid system modular baseplate 24 mm batch number: 15338548.Visual evaluation of the returned device noted it was securely attached to the mating device as intended.No problem was found with the assembly of the device.Functional testing was not performed due to the device being securely assembled to the device for (b)(4).Further visual evaluation noted damage to the edges of the threads of the ar-9561-20s modular 20 mm central screw that are intended for compression and ingrowth.The most likely cause for this failure can be attributed to misuse/mishandling due to the damage to the device.Refer to investigation photos.

• Brand Name: 20MM CENTRAL SCREW, 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: 21458782
• Report Number: 1220246-2025-00640
• Device Sequence Number: 15501043
• Product Code: PHX
• UDI-Device Identifier: 00888867296558
• UDI-Public: (01)00888867296558(11)240906(17)290831(10)15313832
• 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): 05/09/2025

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: 20MM CENTRAL SCREW, MODULAR
• Device Catalogue Number: AR-9561-20S
• Device Lot Number: 15313832
• 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: 05/09/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2024
• 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