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

Model Number	30MM CENTRAL SCREW, MODULAR
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/12/2022
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
It was reported through the surgical outcome system that a revision surgery is required due to a prosthetic joint implant failure.The date of the primary procedure was (b)(6) 2020 for a supscap repair shoulder arthroplasty.Update: (b)(6) 2022: the central screw and one peripheral screw had broken and a revision surgery was performed on (b)(6) 2022 due to the loosening of the baseplate.The problem was identified on (b)(6) 2022.
Additional Manufacturer Narrative
Complaint confirmed.Upon visual inspection, it was noted that the device was received assembled to an ar-9560-28-4.It was noted that the central screw had broken.The cause of this is undetermined.Upon functional testing, it was noted that the devices could not be separated.

• Brand Name: 30MM 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: 14407316
• Report Number: 1220246-2022-04921
• Device Sequence Number: 11382365
• Product Code: PHX
• UDI-Device Identifier: 00888867296572
• UDI-Public: 00888867296572
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K173900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: 30MM CENTRAL SCREW, MODULAR
• Device Catalogue Number: AR-9561-30S
• Device Lot Number: 6855
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2022
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 05/16/2022
• Supplement Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown