MAUDE Adverse Event Report: ARTHREX, INC. GLENOID TARGETER LOCKING NUT; PROSTHESIS, SHOULDER, CEMENTED

Model Number	GLENOID TARGETER LOCKING NUT
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 03/03/2025, a sales representative reported via (b)(4) that an ar-5400-02 vip¿ glenoid targeter handle slid even though both nuts were secured tightly.Ar-5400-04 vip¿ glenoid targeter locking nut, and a second nut from the ar-4500-s set.This occurred during a reverse shoulder arthroplasty on (b)(6) 2025.Additional information was provided on 03/04/2025 where the sales representative stated the arms that didn¿t hold in place were 10,12,15,18,25.Clarification: it was reported that the targeter arms, ar-5400-10, ar-5400-12, ar-5400-15, ar-5400-18, and ar-5400-25 were sliding on the handle, despite both nuts being securely tightened.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-5400-04, batch number: 052317, was received for investigation.Visual evaluation noted discoloration and damage to the threads.Functional testing of the device to known good ar-5400-02 found no issues with the threads, and the devices were able to mate securely.No problem found.Refer to investigation photos.Complaint allegation is not confirmed.

• Brand Name: GLENOID TARGETER LOCKING NUT
• Common Device Name: PROSTHESIS, SHOULDER, CEMENTED
• 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: 21696800
• Report Number: 1220246-2025-01134
• Device Sequence Number: 9058957
• Product Code: KWS
• UDI-Device Identifier: 00888867315365
• UDI-Public: (01)00888867315365(11)231207(10)052317
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K222007
• 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): 08/07/2025

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: GLENOID TARGETER LOCKING NUT
• Device Catalogue Number: AR-5400-04
• Device Lot Number: 052317
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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