MAUDE Adverse Event Report: ARTHREX, INC. GLENOID TARGETER SHAFT; SHOULDER ARTHRO IMPLANT SYSTEM

Model Number	GLENOID TARGETER SHAFT
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 17-feb-2026, it was reported by a sales representative via (b)(4) that an ar-5400-01 glenoid targeter shaft slot b in the shaft did not hold the leg properly.The leg was sliding freely in the b slot of the shaft, making it difficult to keep the leg in the proper position.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: d9, g3, h3, h6 one unpackaged ar-5400-01 glenoid targeter shaft, batch 021950, was received for evaluation.Visual inspection identified significant surface damage, including nicks, scratches, and discoloration.Slot b was found bent, which would prevent the targeter legs from sliding in proper alignment.Due to the extent of the physical damage, functional testing was not performed.The device¿s manufacturing date is 2019, and the condition is consistent with damage sustained over extended use and handling in the field.Based on the observed evidence, the complaint allegation is confirmed.Refer to the investigation photos.

• Brand Name: GLENOID TARGETER SHAFT
• Common Device Name: SHOULDER ARTHRO IMPLANT SYSTEM
• 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: 24558145
• Report Number: 1220246-2026-01319
• Device Sequence Number: 8860096
• Product Code: KWS
• UDI-Device Identifier: 00888867315334
• UDI-Public: (01)00888867315334(11)191219(10)021950
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/09/2026

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: 021950
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2019
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown