MAUDE Adverse Event Report: ARTHREX, INC. 20MM CENTRAL SCREW, MODULAR; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	20MM CENTRAL SCREW, MODULAR
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/10/2021
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
It was reported, during a reverse total shoulder as the surgeon was inserting the ar-9560-24, plate, the ar-9561-20s screw came off from the plate, the screw was in the patients glenoid and the plate became disengaged.The broken plate and screw were removed from the patient.The case was completed by opened a second ar-9560-24 and ar-9561-20s, no patient injury was reported.
Additional Manufacturer Narrative
Complaint confirmed, the hex feature flats are damaged.Further evaluation of the returned mating part ar-9560-24 revealed the hex feature corners are also damage indicating the two devices were attempted to be assembled while misaligned and were never locked.

• Brand Name: 20MM CENTRAL SCREW, MODULAR
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11912191
• Report Number: 1220246-2021-03195
• Device Sequence Number: 3059831
• Product Code: PHX
• UDI-Device Identifier: 00888867296558
• UDI-Public: 00888867296558
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 06/22/2021

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: 09/30/2025
• Device Model Number: 20MM CENTRAL SCREW, MODULAR
• Device Catalogue Number: AR-9561-20S
• Device Lot Number: 8760
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1