MAUDE Adverse Event Report: ARTHREX, INC. GLENOID TARGETER SHAFT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	GLENOID TARGETER SHAFT
Medical Device Problem Codes	Corroded (1131); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
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 08/05/2025, it was reported by a sales representative via (b)(4) that an ar-5400-01 glenoid targeter shaft had an issue.They had trouble loading the targeting leg into the vip targeter.It was noticed that there was a burr on the d slot of the targeting long piece (ar-5400-01) and the marking between d-08 and d-12 was barely visible.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is confirmed by the attached picture, which shows the device was chipped at the edge of the gap and the tip of the device.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 misuse/mishandling due to damage to the device.

• Brand Name: GLENOID TARGETER SHAFT
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER 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: 22884044
• Report Number: 1220246-2025-03621
• Device Sequence Number: 9604458
• Product Code: KWS
• UDI-Device Identifier: 00888867315334
• UDI-Public: 00888867315334
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 12/15/2025

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 SHAFT
• Device Catalogue Number: AR-5400-01
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 08/05/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown