MAUDE Adverse Event Report: ARTHREX, INC. 24MM BASEPLATE, MONOBLOCK SCREW; SHOULDR PROSTH, REVERSE CONFIG

Model Number	24MM BASEPLATE, MONOBLOCK SCREW
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 03/22/2024, it was reported by a sales representative via phone that an ar-9560-24s modular glenoid system monoblock screw baseplate did not slide on the glenoid pin.It appears the screw was not centered, and it was wobbling, not allowing it to seat correctly.The case was completed using a new ar-9560-24s modular glenoid system monoblock screw baseplate.This was discovered during an rts procedure on (b)(6) 2024.
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.
Additional Manufacturer Narrative
The complaint allegation was confirmed.One unpackaged ar-9560-24s was received for investigation.Functional testing doesn't apply to this device.Upon visual inspection, a bend and nicks in the threads were noted.The most likely cause(s) for the reported failure can be attributed to user error, improper bone preparation, or misaligned insertion.According to dfu-0189-6 at revision 0.E.Warnings.19.Failure to properly align and completely seat the components together can lead to disassociation.Proper technique must be followed to ensure there is no bony or soft tissue interference between modular components.All screws must be adequately tightened to ensure they are recessed to prevent mechanical interference between modular components.

• Brand Name: 24MM BASEPLATE, MONOBLOCK SCREW
• 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: 19129613
• Report Number: 1220246-2024-02102
• Device Sequence Number: 6825910
• Product Code: PHX
• UDI-Device Identifier: 00888867296442
• UDI-Public: 00888867296442
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 08/30/2024

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: 04/30/2025
• Device Model Number: 24MM BASEPLATE, MONOBLOCK SCREW
• Device Catalogue Number: AR-9560-24S
• Device Lot Number: 8007
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 08/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2020
• 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