MAUDE Adverse Event Report: ARTHREX, INC. 35MM CENTRAL SCREW, MODULAR; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number 35MM CENTRAL SCREW, MODULAR

Device Problem Material Separation (1562)

Patient Problem Failure of Implant (1924)

Event Date 10/05/2021

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 10/11/2021, it was reported by a sales representative via e-mail that while the surgeon was using an ar-9622 taper assembly press was used to pair the ar-9560-28-2, 28mm +2 lat.Mgs baseplate and ar-9561-35s, 35mm central screw, but upon insertion the baseplate and central screw disassociated.This was discovered during a reverse total shoulder arthroplasty on (b)(6) 2021.The case was completed by removing the central screw from the glenoid with removal driver and then opened new implants with no patient harm.

• Brand Name: 35MM 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: 12737421
• MDR Text Key: 285560200
• Report Number: 1220246-2021-03861
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867296589
• UDI-Public: 00888867296589
• 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,Followup
• Report Date: 11/02/2021

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: 35MM CENTRAL SCREW, MODULAR
• Device Catalogue Number: AR-9561-35S
• Device Lot Number: 6795
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 11/02/2021
• Supplement Dates Manufacturer Received: 10/11/2021
• Supplement Dates FDA Received: 11/02/2021
• Date Device Manufactured: 07/01/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1