MAUDE Adverse Event Report: ARTHREX, INC. 20MM CENTRAL POST, MODULAR; SHOULDR PROSTH, REVERSE CONFIG

Model Number 20MM CENTRAL POST, MODULAR

Device Problem Fitting Problem (2183)

Patient Problem Insufficient Information (4580)

Event Date 10/20/2021

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 improper bone prep and/or misaligned insertion.

Event Description

On 10/28/2021, it was reported by a sales representative via phone that an ar-9105-03 glenoid didn't fit and the ar-9561-20p central post would not engage.This was discovered during use in a reverse arthroplasty on (b)(6) 2021.The case was completed by using a new ar-9105-03 and ar-9561-20p.

• Brand Name: 20MM CENTRAL POST, 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: jared engle ; 8009337001
• MDR Report Key: 19195442
• MDR Text Key: 341291311
• Report Number: 1220246-2024-02485
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867296510
• UDI-Public: 00888867296510
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20MM CENTRAL POST, MODULAR
• Device Catalogue Number: AR-9561-20P
• Device Lot Number: 8961
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1