MAUDE Adverse Event Report: ARTHREX, INC. 4K SYNERGYUHD4 ULTRA, AUTOCLAVABLE; K153218

Model Number	4K SYNERGYUHD4 ULTRA, AUTOCLAVABLE
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 06/14/2023, it was reported by a sales representative via sems that an ar-3210-0031 camera image is blurry.This was discovered during a case with no patient effect.
Additional Manufacturer Narrative
(window) the evaluation determined that the reported event was misuse due to a damaged window.Likely due to mishandling.

• Brand Name: 4K SYNERGYUHD4 ULTRA, AUTOCLAVABLE
• Common Device Name: K153218
• 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: emily shafer ; 8009337001
• MDR Report Key: 17315341
• Report Number: 1220246-2023-07141
• Device Sequence Number: 4057853
• Product Code: GCJ
• UDI-Device Identifier: 00888867279315
• UDI-Public: 00888867279315
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K153218
• 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): 09/27/2023

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: 4K SYNERGYUHD4 ULTRA, AUTOCLAVABLE
• Device Catalogue Number: AR-3210-0031
• Device Lot Number: 117966
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2023
• Supplement Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2018
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown