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

Model Number	30MM CENTRAL SCREW, MODULAR
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 2/5/2024, it was reported by a sales representative via phone that an ar-9561-30s univers revers modular glenoid system, central screw, modular 30 mm disassociated from the baseplate when being implanted.Nothing broke inside the patient, and the screw was retrieved from the patient.Another ar-9561-30s central screw was used to complete the case.There was a 30-minute delay in the procedure, with additional anesthesia administered due to getting the ar-9561-30s central screw from another facility.This was discovered during a reverse shoulder arthroplasty procedure on (b)(6) 2024.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided, including the device (if available and returned), pictures, videos, event descriptions, and any additional field information, arthrex concluded that the cause of the reported failure was a user error setting the device together.The complaint allegation was not confirmed.The device was not received for evaluation, and the customer¿s attached picture does not provide evidence of the failure.
Additional Manufacturer Narrative
Corrected information: h6, h11.Based on the information provided, including the device (if available and returned), pictures, videos, event descriptions, and any additional field information, arthrex concluded that the cause of the reported failure was a user error in setting the device together.When two devices are intended to be threaded together, ensure they are fully engaged before use.The complaint allegation was not confirmed.The device was not received for evaluation, and no evidence of failure was received.

• 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: 18760278
• Report Number: 1220246-2024-01066
• Device Sequence Number: 6329000
• Product Code: PHX
• UDI-Device Identifier: 00888867296572
• UDI-Public: 00888867296572
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,Followup
• Report Date (Section B): 05/16/2025

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: 14977750
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2024
• Supplement Date Received by Manufacturer: 04/23/2025; 05/14/2025
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 05/14/2025; 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/05/2022
• 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