MAUDE Adverse Event Report: ARTHREX, INC. UNI GLENOID-PERIPHERAL LOCK SCRW; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	UNI GLENOID-PERIPHERAL LOCK SCRW
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/09/2022
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
On 12/15/2022 it was reported by a sales representative by email that a ar-9145-48 universal glenoid locking screw broke when being driven into a glenoid.This was discovered during an eclipse tsa w/ convertible universal glenoid on (b)(6) 2022.The tip was removed, but the remainder of the screw was left in the patient.
Event or Problem Description
Additional information received 12/15/22: the procedure was completed by shaving down the tip of the superior broken screw on the universal baseplate that was impeding the inlay poly from seating.The central and inferior peripheral screws were implanted without issue.
Additional Manufacturer Narrative
The complaint is confirmed based on the customer provided photo, which displays the distal end on the implant had broken and damaged threads.However, without the return of the device for physical evaluation, the most likely cause for the reported failure can be attributed to user error of the device due to excessive force, misaligned insertion and/or prying/leveraging the device during use.

• Brand Name: UNI GLENOID-PERIPHERAL LOCK SCRW
• 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: 16086905
• Report Number: 1220246-2023-06016
• Device Sequence Number: 15085302
• Product Code: PHX
• UDI-Device Identifier: 00888867057753
• UDI-Public: 00888867057753
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K142863
• 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): 06/06/2024

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: 03/31/2023
• Device Model Number: UNI GLENOID-PERIPHERAL LOCK SCRW
• Device Catalogue Number: AR-9145-48
• Device Lot Number: 170167313
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2022
• Supplement Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown