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

Model Number	4K SYNERGYUHD4 ULTRA, AUTOCLAVABLE
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during an arthroscopic surgery the camera head heated up.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The reported event was not confirmed.The service evaluation revealed that cable and grasping mechanism are worn out.The most likely cause is attributed to wear and tear.However, there was no overheating or increasing temperature observed during function testing.

• Brand Name: 4K SYNERGYUHD4 ULTRA, AUTOCLAVABLE
• Common Device Name: LAPAROSCOPE
• 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: 22637905
• Report Number: 1220246-2025-03106
• Device Sequence Number: 12759924
• Product Code: GCJ
• UDI-Device Identifier: 00888867279315
• UDI-Public: (01)00888867279315(11)250131(10)NB
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K153218
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2025

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: 4K SYNERGYUHD4 ULTRA, AUTOCLAVABLE
• Device Catalogue Number: AR-3210-0031
• Device Lot Number: NB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 07/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown