MAUDE Adverse Event Report: ARTHREX, INC. 24MM +2 LAT BASEPLATE, MODULAR; SHOULDR PROSTH, REVERSE CONFIG

Model Number 24MM +2 LAT BASEPLATE, MODULAR

Device Problem Fitting Problem (2183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2022

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 most likely cause for the reported failure can be attributed to wear and tear.

Event Description

On 04/26/2022 it was reported by a sales representative via (b)(4) that an ar-9560-24-2 modular glenoid system modular baseplate did nit fit correctly.This was discovered during a procedure, with no patient harm reported.Requested additional information.

• Brand Name: 24MM +2 LAT BASEPLATE, 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: 19067913
• MDR Text Key: 339923927
• Report Number: 1220246-2024-01904
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867296497
• UDI-Public: 00888867296497
• 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: 04/08/2024

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 +2 LAT BASEPLATE, MODULAR
• Device Catalogue Number: AR-9560-24-2
• Device Lot Number: 13289596
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/26/2022
• Initial Date FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2021
• 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