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

Model Number	35MM CENTRAL SCREW, MODULAR
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/05/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 1220246-2021-03861
• Device Sequence Number: 19834745
• Product Code: PHX
• UDI-Device Identifier: 00888867296589
• UDI-Public: 00888867296589
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K173900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: 35MM CENTRAL SCREW, MODULAR
• Device Catalogue Number: AR-9561-35S
• Device Lot Number: 6795
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 11/02/2021
• Date Device Manufactured: 07/01/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown