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	05/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint cannot be confirmed based on the customer provided photos, which display the device as the temperature of the device cannot be determined.Without return of the device for physical evaluation, the cause remains undetermined.No change in harm was identified.
Event or Problem Description
It was reported that the device overheats unconventionally, so that working with the device is not possible.There was no harm for patient, operator or third party reported.No further information received.Update avoe (b)(6) 2022 it was confirmed that the error occurred during an arthroscopic treatment of tendon rupture of the shoulder, which took approx.1.5 to 2 h.The user could hardly hold the device in his hand due to the heat development.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.

• 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: 18661361
• Report Number: 1220246-2024-00836
• Device Sequence Number: 6885406
• Product Code: GCJ
• UDI-Device Identifier: 00888867279315
• UDI-Public: 00888867279315
• 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,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/07/2024

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: 4K SYNERGYUHD4 ULTRA, AUTOCLAVABLE
• Device Catalogue Number: AR-3210-0031
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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