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

Model Number	GLENOID TARGETER SHAFT
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 07/17/2025, it was reported by a sales representative via (b)(4) that an ar-5400-01 glenoid targeter shaft did not allow legs to slide down it.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d2b, d9, g3, h3, h6.Complaint allegation is not confirmed.One unpackaged ar-5400-01 glenoid targeter, titanium shaft batch number: 022034 was received for investigation.Visual evaluation of the returned device noted slight wear and tear to the device.Functional testing was performed with known good glenoid targeter legs and it was found that all could go into the slots of the returned device as intended.No problem found.Refer to investigation photos.

• Brand Name: GLENOID TARGETER SHAFT
• 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: 22727938
• Report Number: 1220246-2025-03275
• Device Sequence Number: 8967847
• Product Code: KWS
• UDI-Device Identifier: 00888867315334
• UDI-Public: 00888867315334
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 10/13/2025

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
• Device Lot Number: 022035
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/17/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown