MAUDE Adverse Event Report: ARTHREX, INC. 24MM BASEPLATE, MONOBLOCK SCREW; SHOULDR PROSTH, REVERSE CONFIG

Model Number 24MM BASEPLATE, MONOBLOCK SCREW

Device Problem Unintended Movement (3026)

Patient Problem Insufficient Information (4580)

Event Date 03/18/2024

Event Type  malfunction  

Event Description

On 03/22/2024, it was reported by a sales representative via phone that an ar-9560-24s modular glenoid system monoblock screw baseplate did not slide on the glenoid pin.It appears the screw was not centered, and it was wobbling, not allowing it to seat correctly.The case was completed using a new ar-9560-24s modular glenoid system monoblock screw baseplate.This was discovered during an rts procedure on (b)(6) 2024.

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: 24MM BASEPLATE, MONOBLOCK SCREW
• 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: jared engle ; 8009337001
• MDR Report Key: 19129613
• MDR Text Key: 340963236
• Report Number: 1220246-2024-02102
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867296442
• UDI-Public: 00888867296442
• 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: 04/17/2024

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
• Device Operator: Health Professional
• Device Model Number: 24MM BASEPLATE, MONOBLOCK SCREW
• Device Catalogue Number: AR-9560-24S
• Device Lot Number: 8007
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2020
• 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