MAUDE Adverse Event Report: THINK SURGICAL TSOLUTION ONE TOTAL KNEE APPLICATION; TCAT

Model Number 108400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Damage to Ligament(s) (1952)

Event Date 08/03/2022

Event Type  Injury  

Manufacturer Narrative

No device malfunction has been reported.The surgeon confirmed his clinical opinion that this event is not caused by the think surgical system.The event was related to the physician assistant's forceful retraction of the tissue and this injury occurred independent of the operation of the think system, and proper training instruction.The surgeon was able to repair the ligament and switched to a ps to provide more stability.In follow up discussions, the surgeon confirmed the patient has progressed well without incident.

Event Description

Following the case, the surgeon mentioned that the medial collateral ligament (mcl) has minimal damaged.The surgeon stated that this was not due to the robot and confirmed with his pa that the burr did not touch the mcl.He stated it was due to the physician assistant's forceful retraction of the tissue.

• Brand Name: TSOLUTION ONE TOTAL KNEE APPLICATION
• Type of Device: TCAT
• Manufacturer (Section D): THINK SURGICAL; 47201 lakeview blvd.; fremont 94538
• Manufacturer (Section G): THINK SURGICAL; 47201 lakeview blvd; fremont 94538
• Manufacturer Contact: meliha mulalic ; 47201 lakeview blvd; fremont 94538 ; 5102492337
• MDR Report Key: 15351498
• MDR Text Key: 299278970
• Report Number: 3000719653-2022-00006
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 108400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male