MAUDE Adverse Event Report: ARTHREX, INC. 25MM CENTRAL POST, MODULAR; SHOULDR PROSTH, REVERSE CONFIG

Model Number 25MM CENTRAL POST, MODULAR

Device Problem Fitting Problem (2183)

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

Event Date 10/06/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023, it was reported by a sales representative via phone that an ar-9561-25p univers revers modular glenoid system, central post, modular 25 mm was not connecting to the glenoid base plate connection.The case was completed opening another ar-9561-25p with no reported delay in the procedure or additional anesthesia administered.No fragments broke inside the patient.This was discovered during a reverse total shoulder procedure on (b)(6) 2023, with no adverse event or patient harm.

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.

• Brand Name: 25MM CENTRAL POST, 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: emily shafer ; 8009337001
• MDR Report Key: 18049050
• MDR Text Key: 327090208
• Report Number: 1220246-2023-08503
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867296527
• UDI-Public: 00888867296527
• 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: 11/01/2023

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: 25MM CENTRAL POST, MODULAR
• Device Catalogue Number: AR-9561-25P
• Device Lot Number: 15047267
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/06/2023
• Initial Date FDA Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/23/2023
• 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