MAUDE Adverse Event Report: ARTHREX, INC. SIZE 14 LEG, GLENOID TARGETER; PROSTHESIS, SHOULDER, CEMENTED

Model Number	SIZE 14 LEG, GLENOID TARGETER
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/29/2024, it was reported by a sales representative via (b)(4) that an ar-5400-14 size 14 leg, glenoid targeter is worn out.This occurred during use in a case with no patient effect.
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.The complaint allegation is confirmed.One unpackaged ar-5400-14 serial/batch number (b)(6) was received for investigation.The returned device was visually inspected, and damage to the slot was noted.Functional testing was performed by assembling an ar-5400-01 lot number: 022201, an ar-5400-02 lot number: 052118, and an ar-5400-04 lot number: 052118 and attempting to slide the ar-5400-14 glenoid targeter leg onto the ar-5400-01; the device would not fit into the ar-5400-01 as there was interference at the beginning of the side rails.Refer to ncr-26054.A supplier manufacturing issue is the cause of the reported failure.

• Brand Name: SIZE 14 LEG, GLENOID TARGETER
• 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: 20733470
• Report Number: 1220246-2024-08568
• Device Sequence Number: 8304362
• Product Code: KWS
• UDI-Device Identifier: 00888867315419
• UDI-Public: (01)00888867315419(11)231027(10)AR10445901
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/03/2025

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: AR10445901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2023
• 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