MAUDE Adverse Event Report: ARTHREX, INC. 24MM BASEPLATE, 20° FULL AUG, OB; SHOULDR PROSTH, REVERSE CONFIG

Model Number 24MM BASEPLATE, 20° FULL AUG, OB

Device Problem Fitting Problem (2183)

Patient Problem Insufficient Information (4580)

Event Date 11/08/2021

Event Type  malfunction  

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.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to user error of the device due to user-applied mechanical forces during assembly.

Event Description

On (b)(6) 2021 it was reported by a sales representative via phone that an ar-9582-30 modular post and ar-9582-2420 24 mm baseplate would not fuse or tension together.This was discovered on the back table during use in a rtsa on (b)(6) 2021.The case was completed by open a new ar-9582-30 and ar-9582 2420.

• Brand Name: 24MM BASEPLATE, 20° FULL AUG, OB
• 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: 19183290
• MDR Text Key: 341716984
• Report Number: 1220246-2024-02405
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867341647
• UDI-Public: 00888867341647
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/25/2024

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, 20° FULL AUG, OB
• Device Catalogue Number: AR-9580-2420
• Device Lot Number: 1027082052
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1