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

Model Number 103306

Device Problem No Apparent Adverse Event (3189)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/12/2019

Event Type  Injury  

Manufacturer Narrative

During removal of fixation pins after surgery was completed, the femur fixation pin snapped off by the threads.The broken end of pin was successfully removed from the patient.Under magnification there does not appear to be any material defects at the location of the break, such as air pockets or hairline cracks and the pin does not appear to be bent or deformed.The pin was removed with a broken screw removal kit and needle nose pliers.The pin was removed successfully without additional intervention.No further corrective action is necessary.We will monitor via the complaint process for additional instances of broken pins and will take action as warranted.

Event Description

During removal of fixation pins after surgery was completed, the femur fixation pin was being removed by hand with our t-handle wrench 101884 and snapped off by the threads.The broken end of pin was successfully removed from the patient.

• Brand Name: TSOLUTION ONE TOTAL KNEE APPLICATION
• Type of Device: TCAT
• Manufacturer (Section D): THINK SURGICAL INC.; 47201 lakeview blvd; fremont CA 94538
• Manufacturer (Section G): THINK SURGICAL, INC.; 47201 lakeview blvd; fremont CA 94538
• Manufacturer Contact: meliha mulalic ; 47201 lakeview blvd; fremont, CA 94538 ; 5102492337
• MDR Report Key: 14948022
• MDR Text Key: 295452662
• Report Number: 3000719653-2019-00001
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K191369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/07/2022

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
• Device Model Number: 103306
• Device Lot Number: 12091
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2019
• Initial Date FDA Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic
• Patient Race: White