MAUDE Adverse Event Report: ARTHREX, INC. 30MM CENTRAL SCREW, MODULAR; SHOULDR PROSTH, REVERSE CONFIG

Model Number	30MM CENTRAL SCREW, MODULAR
Medical Device Problem Code	Damaged Thread (4075)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/15/2024
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 01/16/2024, it was reported by a sales representative via email that an ar-9560-24-2 arthrex univers revers modular glenoid system modulas baseplate 24 mm +2 lat and an ar-9561-30s univers revers modular glenoid system, central screw modular 30 mm cold-welded together on the press.When separating the modular glenoid system modulas baseplate from the screw, it stripped.This was discovered during a procedure on (b)(6) 2024.Additional information requested.
Additional Manufacturer Narrative
The complaint allegation was confirmed.One unpackaged ar-9561-30s was received for investigation.Functional testing was not performed due to the damaged to the device connector.The visual evaluation found that the hex was damaged, revealing nicks.The most likely cause for the reported failure is user error following the device's surgical technique.When two devices are intended to be threaded together, ensure that they are fully engaged prior to use.

• Brand Name: 30MM CENTRAL SCREW, MODULAR
• Common Device Name: SHOULDR PROSTH, REVERSE CONFIG
• 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: jared engle ; 8009337001
• MDR Report Key: 18649146
• Report Number: 1220246-2024-00779
• Device Sequence Number: 20629801
• Product Code: PHX
• UDI-Device Identifier: 00888867296572
• UDI-Public: 00888867296572
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 08/28/2024

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 Model Number: 30MM CENTRAL SCREW, MODULAR
• Device Catalogue Number: AR-9561-30S
• Device Lot Number: 15149258
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2024
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown