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

Model Number 108400

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/27/2022

Event Type  Injury  

Event Description

While the tcat was cutting the femur, the patient coughed, and we experienced an epo.The surgeon was able to recover and continue with cutting.Before the tcat could complete 50% of the tibial cut, the pa noticed a small dribble of unknown black fluid running down the patient's leg below the incision site.Upon further inspection, the liquid appeared to be coming from the cutter sleeve.When the surgeon wiped the side of the cutter drive with gauze, there was a black substance.He immediately aborted the case and continued the tibial cut manually.After taking the cutter out of the cutter sleeve, it was noticed a gooey black substance at the base of the cutter.No additional black residue was present on the side of the cutter sleeve.During a follow-up conversation with the surgeon, he stated that he did not see the black fluid in the joint.

Manufacturer Narrative

The cutter drive assembly (cda) was received on 7/22/2022 and examined.The cda was disassembled and closely examined to determine if it was built properly, components and features designed into the cda to prevent fluid migration are present, including the vent hole and rotary seal.The vent hole was also checked and clear of any blockage.The rotary seal was closely examined to make sure that it was installed correctly, and it was found to be in place and intact, thus we have concluded that the cda was assembled and working correctly.The purpose of the vent hole and the rotary seal is to prevention fluid migration into the chuck and motor, and both these features have been thoroughly tested and documented.It should be noted that the inside of the cutter drive chuck and the motor are very dry and clean, thus it appears no fluid migrated into these areas.A cylindrical shaped black substance which came out of the cda when the cutter was removed, this could have been buildup of material that may have momentarily obstructed the vent hole.If this happened it would have allowed the saline/bone fluid to become burned due to the friction of the bearings and caused the black fluid.Once the obstruction had cleared, it would have leaked this fluid through the vent hole.

• 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: 15114716
• MDR Text Key: 296711689
• Report Number: 3000719653-2022-00003
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 108400
• Device Catalogue Number: 109142, 105745
• Device Lot Number: 20F0031, 135680036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2021
• 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: Female