MAUDE Adverse Event Report: ARTHREX, INC. SIZE 14 LEG, GLENOID TARGETER; ORTHOPEDIC MANUAL SURG INSTR

Model Number	SIZE 14 LEG, GLENOID TARGETER
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
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 02/27/2025, a sales representative reported via (b)(4) that an ar-5400-14 vip¿ glenoid targeter will no longer slide into the shaft.The leg seems to not move freely up and down the shaft as it should.This issue was discovered during the case but the patient was not affected.
Additional Manufacturer Narrative
One unpackaged ar-5400-14 glenoid targeter leg, lot number: 10445901, was received for investigation.Visual evaluation of the device noted nicks and damage along the body.Functional testing was performed by attempting to slide the ar-5400-14 glenoid targeter leg onto the ar-5400-01.Functional testing noted that the device would not properly slide all the way down as intended and was met with resistance.Refer to ncr-26054.A supplier manufacturing issue is the cause of the reported failure.Refer to the investigation photos.The complaint allegation is confirmed.

• Brand Name: SIZE 14 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: 21619934
• Report Number: 1220246-2025-00984
• Device Sequence Number: 18270370
• Product Code: KWS
• UDI-Device Identifier: 00888867315419
• UDI-Public: 00888867315419
• 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): 06/27/2025

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: SIZE 14 LEG, GLENOID TARGETER
• Device Catalogue Number: AR-5400-14
• Device Lot Number: 10445901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 06/27/2025
• 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