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

Model Number 24MM +2 LAT BASEPLATE, MODULAR

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 03/26/2024

Event Type  malfunction  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

On 3/26/2024, it was reported by a sales representative via email that an ar-9560-24-2 modulas baseplate disassociated from an ar-9561-25s central screw during insertion.This was discovered during a rtsa procedure on (b)(6) 2024.Additional information requested.

• 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: 19152296
• MDR Text Key: 341001792
• Report Number: 1220246-2024-02198
• 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: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• 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: 15196062
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/22/2024
• 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