MAUDE Adverse Event Report: ARTHREX, INC. CCU, ARTHREX SYNERGY UHD4; LAPAROSCOPE

Model Number	CCU, ARTHREX SYNERGY UHD4
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2023
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 the fiber optic cable becomes very hot during optical connection.There was no harm for patient, operator or third party reported.There was no case involvement reported.No further information received.Update dw 22-dec-2023: the reported issue was noticed during a surgery.Update swit 02-jan-2024: a shoulder arthroscopy was performed.There was no harm for patient, operator or third party.The cable did not come in contact with the patient.The surgery was finished successfully with the same light guide cable.Update dw 10-jan-2024: further information were provided that the event is not related to the used cables and not the ccu with the part number ar-3240-5027.Update dw 29-jan-2024: the number of affected devices and lot number of the defective cables were provided.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.(no problem found) the evaluation did not identify any issues relevant to the reported event.

• Brand Name: CCU, ARTHREX SYNERGY UHD4
• 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: emily shafer ; 8009337001
• MDR Report Key: 18607925
• Report Number: 1220246-2024-00608
• Device Sequence Number: 9017045
• Product Code: GCJ
• UDI-Device Identifier: 00888867197022
• UDI-Public: 00888867197022
• 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,Followup
• Report Date (Section B): 12/11/2024

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: CCU, ARTHREX SYNERGY UHD4
• Device Catalogue Number: AR-3200-0021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2023
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2023
• 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