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

Model Number 4K SYNERGYUHD4 ULTRA, AUTOCLAVABLE

Device Problems Display or Visual Feedback Problem (1184); Image Display Error/Artifact (1304)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/14/2023

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 319925637
• Report Number: 1220246-2023-07141
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00888867279315
• UDI-Public: 00888867279315
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153218
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 06/14/2023
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: 06/14/2023
• Supplement Dates FDA Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1