MAUDE Adverse Event Report: ARTHREX, INC. SIZE 20 LEG, GLENOID TARGETER; PROSTHESIS, SHOULDER, CEMENTED

Model Number	SIZE 20 LEG, GLENOID TARGETER
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 03/29/2023, it was reported by a sales representative via sems that an ar-5400-20 glenoid targeter "foot piece" was sliding up and down the pencil tip.This occurred during a case, they tried the other size 20 and it worked just fine, so they're thinking this one may just be old/overused.This occurred during an rtsa on (b)(6) 2023.No additional information provided.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.  arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint device was not received for evaluation.Based off the information provided, the most likely cause of the reported failure is wear and tear.

• Brand Name: SIZE 20 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: 19559983
• Report Number: 1220246-2024-05969
• Device Sequence Number: 6805986
• Product Code: KWS
• UDI-Device Identifier: 00888867315471
• UDI-Public: 00888867315471
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 06/18/2024

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 20 LEG, GLENOID TARGETER
• Device Catalogue Number: AR-5400-20
• Device Lot Number: 052027
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown