MAUDE Adverse Event Report: ARTHREX, INC. GLENOID TARGETER HANDLE; VIRTUAL IMPLANT POSITIONING

Model Number	GLENOID TARGETER HANDLE
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 2/3/2023, it was reported by a sales representative via sems that an ar-5400-02 glenoid targeter handle had an issue.The top part of the item was loose and seemed to bend when trying to engage.They had to open up another pan and use the one from it.This was discovered during use with no impact to the patient.
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.Complaint is not confirmed.One unpackaged ar-5400-02 glenoid handle serial/batch number 052027r was received for investigation.Functional testing found that the device is functioning as required.Visual evaluation found not issues with the device.

• Brand Name: GLENOID TARGETER HANDLE
• Common Device Name: VIRTUAL IMPLANT POSITIONING
• 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: 19459367
• Report Number: 1220246-2024-04837
• Device Sequence Number: 12755604
• Product Code: KWS
• UDI-Device Identifier: 00888867315341
• UDI-Public: 00888867315341
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2024

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: GLENOID TARGETER HANDLE
• Device Catalogue Number: AR-5400-02
• Device Lot Number: 052027R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2021
• 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