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

Model Number	35MM CENTRAL SCREW, MODULAR
Health Effect - Clinical Codes	Failure of Implant (1924); Foreign Body In Patient (2687)
Date of Event	10/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint confirmed, the ar-9560-24-4 and mating ar-9561-35s did not mate.Nothing broke off from the devices.The hex features were found to be damaged, indicating the devices were attempted to be assembled while they were not aligned.
Event or Problem Description
On 10/29/2021, it was reported by a sales representative via e-mail that an ar-9560-24-4 and ar-9561-35s baseplate broke off, leaving screw inside of the patient.The surgeon was able to remove the fragment.This was discovered during a procedure on (b)(6) 2021.The case was completed by using a new ar-9560-24-4 and ar-9561-35s.Additional information provided 10/29/2021: procedure being performed was a reverse total shoulder.The broken screw was removed from the patient.Bone quality of the patient was good.The 35mm tap was used to prepare the bone socket.The case was completed by using the 4.0 hex driver from mgs 2 to remove the screw.We opened a new baseplate and central screw (downsized to 30mm) and were able to successfully complete the case.

• 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: 12819073
• Report Number: 1220246-2021-03940
• Device Sequence Number: 1792221
• 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
• Report Date (Section B): 11/16/2021

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: 07/31/2025
• Device Model Number: 35MM CENTRAL SCREW, MODULAR
• Device Catalogue Number: AR-9561-35S
• Device Lot Number: 8765
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown