MAUDE Adverse Event Report: ARTHREX, INC. 30MM CENTRAL SCREW, MODULAR; SHOULDR PROSTH, REVERSE CONFIG

Model Number 30MM CENTRAL SCREW, MODULAR

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 05/20/2022

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 can be attributed to user error due incorrect assembly.

Event Description

On (b)(6) 2022, it was reported by a sales representative via email that an ar-9560-24 univers revers modular glenoid system modulas baseplate, and an ar-9561-30s univers revers modular glenoid system central screw, dissociated during implantation.On the assembly press, proper hex alignment between baseplate and central screw was found via gentle rotation of screw until it fell flush to the back of the baseplate.The baseplate was aligned on the correct small/large pegs.The press was cranked down/pressured the morse tape together until the laser line was between min/max.Implant was threaded onto inserter and placed into glenoid.During rotation of screwing the implant into glenoid, the baseplate popped off the central screw, leaving the screw in the glenoid.It was removed cleanly with the hex driver from the mgs 2 tray.Additional information received on 5/23/2022: case was completed using a new baseplate and central screw, no further issues has been reported.

• Brand Name: 30MM CENTRAL SCREW, 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: 19008454
• MDR Text Key: 338986952
• Report Number: 1220246-2024-01743
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867296572
• UDI-Public: 00888867296572
• 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

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 30MM CENTRAL SCREW, MODULAR
• Device Catalogue Number: AR-9561-30S
• Device Lot Number: 14605284
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/24/2021
• 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