MAUDE Adverse Event Report: ARTHREX, INC. SIZE 25 LEG, GLENOID TARGETER; PROSTHESIS, SHOULDER, CEMENTED

Model Number	SIZE 25 LEG, GLENOID TARGETER
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
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
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) 025.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
Additional information: g3, h3, h6.Complaint allegation is not confirmed.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to a manufacturing issue; however, due to the device not being returned, we are unable to confirm the reported event.

• Brand Name: SIZE 25 LEG, GLENOID TARGETER
• 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: 21696754
• Report Number: 1220246-2025-01139
• Device Sequence Number: 21045001
• Product Code: KWS
• UDI-Device Identifier: 00888867315525
• UDI-Public: 00888867315525
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

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: SIZE 25 LEG, GLENOID TARGETER
• Device Catalogue Number: AR-5400-25
• 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: 08/29/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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