MAUDE Adverse Event Report: ARTHREX, INC. 4.5X36MM PERIPHERAL SCREW, NON-LOCKING; SHOULDR PROSTH, REVERSE CONFIG

Model Number	4.5X36MM PERIPHERAL SCREW, NON-LOCKING
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 04/10/2025, it was reported by a sales representative via email that an ar-9562-36nl peripheral screw was received defective with the screw head not fitting the proper hex driver.No further information was provided.This was discovered during a procedure on (b)(6) 2025, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged univers revers¿ modular glenoid system, peripheral screw, non-locking 4.5 x 36 mm, batch number 15022107, was received for investigation.Visual inspection noted that the device was damaged around the hex of the screw head.The ¿go¿ hex gauge was found not to fit, indicating that the hex is undersized and does not meet the required dimensional tolerance.Furthermore, the hex's ¿wall-to-wall¿ measurement is.1091-.1096, compared to the drawing's lower specification of.1185.This is a known manufacturing issue addressed through capa.The screw was manufactured in 2022, prior to the capa implementation actions.- refer to investigation photos.- the complaint allegation is confirmed.

• Brand Name: 4.5X36MM PERIPHERAL SCREW, NON-LOCKING
• 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: 21984519
• Report Number: 1220246-2025-01947
• Device Sequence Number: 8480161
• Product Code: PHX
• UDI-Device Identifier: 00888867296732
• UDI-Public: (01)00888867296732(11)221110(17)271031(10)15022107
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/09/2025

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: 4.5X36MM PERIPHERAL SCREW, NON-LOCKING
• Device Catalogue Number: AR-9562-36NL
• Device Lot Number: 15022107
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown