MAUDE Adverse Event Report: ARTHREX, INC. SALES LEVEL,CCU,SYNERGY HD3,TURRET; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	SALES LEVEL,CCU,SYNERGY HD3,TURRET
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
The device was received by arthrex (b)(4) from the customer with a note that stated ¿tower does not make a connection".The problem was noticed during the surgery.No further information received.Additional information obtained 24-mar-2020: further information was provided that the reported event occurred during a knee arthroscopy.The patient was already in the surgery room and prepared for the surgery but due to the reported issue the surgery was cancelled.A second surgery is planned but due to the covid-19 situation the surgery date is unclear.Additional information obtained 09-apr-2020: the patient was already under anesthesia when it was noticed that device did not work.The hospital did not have an replacement system on site and ready for use.
Additional Manufacturer Narrative
(sw bug actsw-21246) the evaluation determined that the reported event was caused by a software bug (actsw-21246).

• Brand Name: SALES LEVEL,CCU,SYNERGY HD3,TURRET
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9963496
• Report Number: 1220246-2020-01792
• Device Sequence Number: 11448216
• Product Code: GCJ
• UDI-Device Identifier: 00888867029163
• UDI-Public: 00888867029163
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SALES LEVEL,CCU,SYNERGY HD3,TURRET
• Device Catalogue Number: AR-3200-0001T
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 08/02/2021
• Patient Sequence Number: 1