MAUDE Adverse Event Report: ARTHREX, INC. 30MM CENTRAL SCREW, MODULAR; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number 30MM CENTRAL SCREW, MODULAR

Device Problems Detachment of Device or Device Component (2907); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2020

Event Type  Injury  

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.

Event Description

It was reported that the modular glenoid system was assembled and pressed together with the press.During a reverse shoulder arthroplasty the surgeon has inserted the glenoid system with the central screw and with the last turn into the glenoid a "clicking" noise was recognized and the central screw became detached from the base plate.The central screw was totally screwed in the glenoid therefore the surgeon decided to left the screw inside the glenoid.The surgeon attached the same base plate onto the central screw inside the patient and fixated the plate with four peripheral non locking screws to finish the surgery successfully.There was no harm for patient, operator or third party reported.

• Brand Name: 30MM CENTRAL SCREW, MODULAR
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: vik bajnath ; 8009337001
• MDR Report Key: 10308301
• MDR Text Key: 199908733
• Report Number: 1220246-2020-01963
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867296572
• UDI-Public: 00888867296572
• 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,health professional,u
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: 30MM CENTRAL SCREW, MODULAR
• Device Catalogue Number: AR-9561-30S
• Device Lot Number: 6405
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/06/2020
• Initial Date FDA Received: 07/22/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other