MAUDE Adverse Event Report: ARTHREX, INC. 25MM CENTRAL SCREW, MODULAR; SHOULDR PROSTH, REVERSE CONFIG

Model Number	25MM CENTRAL SCREW, MODULAR
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 5/5/2022, it was reported by a sales representative via email that an ar-9561-25s univers revers central screw and an ar-9560-24 univers revers baseplate disassociated when surgeon attempted to insert it into the patient's glenoid.Surgeon assemble them but fell apart again during insertion.Another baseplate and central screw were opened and case was completed without further issues.This was discovered during a procedure.Additional information received on 5/6/2022: this was discovered during a rtsa procedure on (b)(6) 2022.Nothing broke inside the patient and case was completed successfully.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Not confirmed.The most likely cause for the reported failure can be attributed to user error due incorrect assembly.

• Brand Name: 25MM 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: 19008426
• Report Number: 1220246-2024-01742
• Device Sequence Number: 8501087
• Product Code: PHX
• UDI-Device Identifier: 00888867296565
• UDI-Public: 00888867296565
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K173900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/29/2024

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 Expiration Date: 02/28/2026
• Device Model Number: 25MM CENTRAL SCREW, MODULAR
• Device Catalogue Number: AR-9561-25S
• Device Lot Number: 9548
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2022
• Initial Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown