MAUDE Adverse Event Report: ARTHREX, INC. 24MM +4 LAT BASEPLATE, MODULAR; SHOULDR PROSTH, REVERSE CONFIG

Model Number 24MM +4 LAT BASEPLATE, MODULAR

Device Problem Defective Device (2588)

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

Event Date 11/30/2022

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.Complaint confirmed.Upon visual evaluation, it was noted that the central screw was not fully seated on the baseplate.It was also noted that the description provided reported resistance encountered and then a loud cracking that was heard.Per the surgical technique, there is a hex feature that must be aligned between the baseplate and the central screw resulting in a tactile coupling and allowing the taper to engage.When the hex feature is not aligned properly and the taper is attempted to be engaged, the hex feature will break and compress blocking the central screw from being able to fully seat.The most likely cause can be attributed to use error due to not following the surgical technique as required.

Event Description

It was reported that during an inverse shoulder prosthesis surgery with mgs the surgeon experienced issues with the screw and the plate.When the surgeon merged the baseplate and screw he experienced first a resistance, then loud cracking.After that the screw could be inserted completely.According to the surgeon the screw was slightly tilted and therefore not 100% stable.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: 24MM +4 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: 19020793
• MDR Text Key: 339141978
• Report Number: 1220246-2024-01777
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867296473
• UDI-Public: 00888867296473
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K173900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/02/2024

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 +4 LAT BASEPLATE, MODULAR
• Device Catalogue Number: AR-9560-24-4
• Device Lot Number: 14774693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2023
• Initial Date Manufacturer Received: 12/05/2022
• Initial Date FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2021
• 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