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 Codes	Use of Device Problem (1670); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
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 10/14/2025, it was reported by a sales representative via (b)(4) that an ar-5400-13 glenoid targeter would not slide down the vip targeting guide.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 the complaint device was not received for evaluation.Based on the information provided, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The cause of the reported failure is a supplier manufacturing issue.Refer to the nonconformance for details.The complaint allegation was confirmed based on the ncr findings.

• 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: 23413090
• Report Number: 1220246-2025-04867
• Device Sequence Number: 21071969
• Product Code: KWS
• UDI-Device Identifier: 00888867315402
• UDI-Public: 00888867315402
• 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): 02/20/2026

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
• Device Lot Number: AR10040401
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 10/14/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown