MAUDE Adverse Event Report: ARTHREX, INC. SIZE 13 LEG, GLENOID TARGETER; ORTHOPEDIC MANUAL SURG INSTR

Model Number	SIZE 13 LEG, GLENOID TARGETER
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
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 06-jan-2026, a facility representative reported via (b)(4) that an ar-5400-13 vip glenoid targeter leg was no longer locking correctly into the glenoid targeter shaft due to becoming warped from wear and tear during a case.No patient was affected.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation is confirmed.One unpackaged ar-5400-13 serial/batch number (b)(6) was received for investigation.Functional testing was performed and revealed that the device could be inserted in the glenoid targeter shaft, but it was slightly difficult.Visual inspection noted that the laser markings are beginning to fade away, and the device is experiencing normal signs of wear and tear.Also, corrosion/degradation was noticed along the device.The most likely cause is attributed to wear and tear due to repeated use of the device.

• Brand Name: SIZE 13 LEG, GLENOID TARGETER
• 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: 24129962
• Report Number: 1220246-2026-00261
• Device Sequence Number: 18741967
• Product Code: KWS
• UDI-Device Identifier: 00888867315402
• UDI-Public: 00888867315402
• 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: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2026

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: SIZE 13 LEG, GLENOID TARGETER
• Device Catalogue Number: AR-5400-13
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 03/13/2026
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown