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

Model Number 30MM CENTRAL SCREW, MODULAR

Device Problem Compatibility Problem (2960)

Patient Problem Insufficient Information (4580)

Event Date 12/14/2023

Event Type  malfunction  

Event Description

On 12/14/2023, it was reported by a sales representative via e-mail that an ar-9561-30s univers revers¿ modular glenoid system had an issue marrying the central screw to the ar-9560-24-2 base plate.This occurred during a reverse total shoulder on (b)(6) 2023, where the central screw did not marry to the base plate, and the metal ended up getting a little deformed.They followed all the correct steps from the technique guide and made sure the screw married the base plate correctly before tightening down with the clamp.No additional information was provided, and additional information has been asked.

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.

• Brand Name: 30MM CENTRAL SCREW, MODULAR
• Type of Device: 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: emily shafer ; 8009337001
• MDR Report Key: 18477995
• MDR Text Key: 333094731
• Report Number: 1220246-2024-00224
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867296572
• UDI-Public: 00888867296572
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 30MM CENTRAL SCREW, MODULAR
• Device Catalogue Number: AR-9561-30S
• Device Lot Number: 15100631
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/05/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1