MAUDE Adverse Event Report: ARTHREX, INC. GLENOID TARGETER HANDLE; ORTHOPEDIC MANUAL SURG INSTR

Model Number	GLENOID TARGETER HANDLE
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) 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.
Event or Problem Description
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: b5, d9, g3, h3, h6.One unpackaged ar-5400-02 vip¿ glenoid targeter, handle batch number: 052317, was received for investigation.Visual evaluation noted discoloration and damage to the threads, which is likely related to the complaint allegation.Functional testing of the device with a known good device noted that the device did not mate securely.The most likely cause of the reported failure is wear and tear.Due to continuous mechanical forces applied to it, the device will inevitably sustain damage over time.The manufacturing date is in december 2023.Refer to investigation photos.Complaint allegation is confirmed.

• Brand Name: GLENOID TARGETER HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 21662875
• Report Number: 1220246-2025-01092
• Device Sequence Number: 18229515
• Product Code: KWS
• UDI-Device Identifier: 00888867315341
• UDI-Public: (01)00888867315341(11)231219(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 HANDLE
• Device Catalogue Number: AR-5400-02
• 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: 03/21/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2023
• 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