MAUDE Adverse Event Report: ARTHREX, INC. 30MM CENTRAL SCREW, MODULAR; SHOULDR PROSTH, REVERSE CONFIG

Model Number	30MM CENTRAL SCREW, MODULAR
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 06/12/2025, a sales representative reported via email that an ar-9560-24 baseplate 24 mm and an ar-9561-30s central screw 30 mm were being implanted when the screw disassociated from the baseplate.Before pressing the two implants together it was confirmed that the screw was correctly seated onto the baseplate, and the components were pressed together properly.During implantation, they attempted an adjustment, and when the baseplate came out, the screw stayed in.Both components appeared stripped.The case was completed, and no further details were provided.This was discovered during a reverse total shoulder on (b)(6) 2025, with no reported patient harm.Additional information was received on 06/27/2025: during the procedure, the screw and baseplate appeared to disassociate while being implanted.Both components were successfully extracted using the appropriate removal instruments, and the case proceeded without complication.The baseplate was replaced with part number: ar-9560-24, and the screw was replaced with part number: ar-9561-30s.There was a minimal case delay and a limited time required to remove and replace the components.No additional anesthesia was administered.No instruments beyond the standard removal tools were used, and no further bone preparation was necessary.The patient¿s bone quality was reported as good.There was no breakage of the implant or instruments.Both the screw and baseplate were fully retrieved.There were no reports of adverse effects on or after the 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: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error due to misalignment of the threads and/or not meeting torque requirements when tightening the locking screw.The dfu for this device, dfu-0189-eo revision 7, gives the following warning: 9.Failure to achieve the appropriate torque requirements when tightening locking screws may result in the premature loosening of the device.

• Brand Name: 30MM 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: 22455770
• Report Number: 1220246-2025-02794
• Device Sequence Number: 8316503
• Product Code: PHX
• UDI-Device Identifier: 00888867296572
• UDI-Public: (01)00888867296572(11)241216(17)291130(10)15362060
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 10/13/2025

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: 30MM CENTRAL SCREW, MODULAR
• Device Catalogue Number: AR-9561-30S
• Device Lot Number: 15362060
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/12/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown