SURETRAC ELASTIC TRACTION SYSTEM

Description of Event or Problem

ON (B)(6) 2025. MICRO-TECH RECEIVED A NOTIFICATION FROM FDA REGARDING SURETRAC ELASTIC TRACTION SYSTEM. IT WAS REPORTED THAT "DID AN INACCURACY OCCUR? YES. WHAT WAS THE ESTIMATED AMOUNT OF INACCURACY? (MM) 10-20MM.WHAT WAS THE DIRECTION OF INACCURACY; MEDIAL DIRECTION ON THE PATIENT'S RIGHT SIDE, LATERAL DIRECTION ON THE PATIENT'S LEFT SIDE.REGISTRATION METHOD AUTO-REGISTRATION (O-ARM, C-ARM). WHEN DID THE INACCURACY OCCUR? DURING NAVIGATION. WHICH INSTRUMENTS WERE BEING USED WHEN INACCURACY WAS DETECTED? STRYKER DRILL WITH SURTRAC DEVICE, AWL TIP TAP, VOYAGER 5.5 SCREWDRIVER MAS, PASSIVE PLANER PROBE. IS THE INACCURACY ISOLATED TO ONE INSTRUMENT, ALL, OR SOME? PLEASE DESCRIBE ALL INSTRUMENTS SEEMED INACCURATE. PHYSICIAN WAS USING A STRYKER ANGLED DRILL WITH A SURTRAC TRACKER ON THE DRILL AND IT WAS REGISTERED APPROPRIATELY PRIOR TO THE INITIAL O-ARM SPIN. THE SURGEON WAS TOLD BY SEVERAL PEOPLE THAT THE DRILL ISN'T AS TRUSTWORTHY AS A NAVIGATED STEALTH MIDAS AND TO NOT TRUST ANY PROJECTIONS FROM THAT DRILL AND TO INSTEAD SHOOT NEGATIVE/ POSITIVE PROJECTIONS OFF THE PASSIVE PLANER PROBES, TAPS, ETC. I SAVED PROJECTIONS OFF THOSE INSTRUMENTS TO ENSURE THEY ALL LINED UP, AND THEY DID WHICH LEAVES ME TO CONFIRM THERE WAS MOVEMENT IN THE FRAME ITSELF, AND IT WASN'T APPROPRIATELY SECURED ON THE PATIENT'S SPINOUS PROCESS. AND AFTER REVIEWING THE SCAN THE PHYSICIAN REMOVED THE T12 AND L1 SCREWS BILATERALLY AND DID NOT REPLACE THEM. THE NOTED INACCURACY WAS 10-20MM.THERE WAS A DELAY OF LESS THAN ONE HOUR. THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME."

Additional Manufacturer Narrative

AT PRESENT, WE HAVE NOT OBTAINED ANY INFORMATION RELATED TO THE DEVICE AND CANNOT CONTACT THE REPORTER. WE WILL CONTINUE TO INVESTIGATE AND TRY TO GET MORE INFORMATION FOR ANALYSIS.

Additional Manufacturer Narrative

ON JUNE 13, 2025, WE COMMUNICATED WITH OUR DISTRIBUTOR TO INVESTIGATE SPECIFIC CLINICAL USAGE INFORMATION. ON JUNE 17, 2025, THE DISTRIBUTOR REPLIED THAT SINCE THE REPORT WAS ANONYMOUS, FURTHER INVESTIGATION WAS NOT POSSIBLE. ON JULY 10, 2025, MICRO-TECH COMMUNICATED WITH THE FDA AND FDA WAS CURRENTLY UNABLE TO PROVIDE ANY OTHER INFORMATION DUE TO CONFIDENTIALITY CONCERNS. WE CHECKED THE INCIDENT DESCRIPTION. NO CONTENT RELATED TO THE SURETRAC ELASTIC TRACTION SYSTEM HAS BEEN FOUND. THE MDR NUMBER OF OTHER ASSOCIATED INCIDENTS MENTIONED IN THE INCIDENT DESCRIPTION IS MW5170979. AFTER CONFIRMATION, THERE IS ALSO NO CONTENT RELATED TO THE SURETRAC ELASTIC TRACTION SYSTEM IN ITS INCIDENT DESCRIPTION, AND ALL OF ITS CONTENT DESCRIBES THE DEVICES OF OTHER COMPANIES. THERE IS NO LOT INFORMATION, FEEDBACK PERSONNEL, OR ADDRESS FOR THIS INCIDENT. AFTER COMMUNICATION WITH THE DISTRIBUTOR AND FDA, NO RELEVANT INFORMATION WAS PROVIDED. DUE TO THE INABILITY TO GET ANY INFORMATION OF THE INCIDENT, IT CANNOT BE ANALYZED AND NO MEASURES WILL BE TAKEN AT THIS TIME. MICRO-TECH WILL CONTINUE TO MONITOR TO ENSURE PATIENT SAFETY.