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

Model Number 24MM BASEPLATE, MODULAR

Device Problem Defective Device (2588)

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

Event Date 08/05/2022

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.Not confirmed.The most likely cause for the reported failure is use error due to over-torquing of the device during use.

Event Description

It was reported on 08/05/2022 by a sales representative via email that an ar-9561-30s and ar-9560-24 screw and baseplate would not fit together and were stripped.This was discovered during a case with no patient harm.

• Brand Name: 24MM 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: 19008527
• MDR Text Key: 339142990
• Report Number: 1220246-2024-01745
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867296411
• UDI-Public: 00888867296411
• 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: 03/29/2024

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, MODULAR
• Device Catalogue Number: AR-9560-24
• Device Lot Number: 14950258
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/05/2022
• Initial Date FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/13/2022
• 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