CLEAR-TRAC 72200903Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 03596010595119), received between Oct 24, 2018 and Mar 2, 2026 — classified as 5 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Break” (18 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Break

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, A PIECE OF A CANNULA FELL OFF INTO THE JOINT. ALL PIECES WERE REMOVED FROM THE PATIENT BY FLUSHING OUT WITH FLUID. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY, USING THE SAME DEVICE. ADDITIONAL ANESTHESIA WAS REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24490779 ↗
• MalfunctionJan 19, 2026Break; Unstable

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, IT WAS NOTICED THAT THE WHITE THREAD OF THE CANNULA WAS LOOSE AND THE INNER EDGES THAT HOOK ONTO THE GREEN PART WERE BROKEN WHEN IT WAS PASSED THROUGH WITH THE DILATOR. NO PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED WITHOUT ANY SURGICAL DELAY, USING AN EQUIVALENT S+N BACK UP PRODUCT. PATIENT IS STABLE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24109382 ↗
• MalfunctionJan 9, 2026Break; Leak/Splash; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE, IT WAS NOTICED THAT THE CANNULA THREADED DISP 8.5 X 72MM HAD A LEAK BETWEEN THE WHITE AND GREEN PARTS AFTER AFTER IT WAS INSERTED WITH A WISINGER GUIDE WIRE, THEN, THE WHITE PART CAME LOOSE WHEN THE WORKING FORCEPS WERE INSERTED. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP PRODUCT. PATIENT IS STABLE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24022896 ↗
• MalfunctionMay 28, 2025Flaked; Flaked

  IT WAS REPORTED THAT DURING A PROCEDURE, IT WAS OBSERVED THAT ONE 8.5X72 CANNULA THREADED WAS DAMAGED UPON BEING USED IN A PATIENT. ONE OF THE RUBBER SEALS WAS RIPPED, AND DEBRIS BEGIN FLOATING IN THE JOINT. THE SURGEON BELIEVES HE GOT ALL OF THE REMNANTS OUT BUT IT IS UNKNOWN HOW. IT IS UNKNOWN IF THERE WAS ABACK UP DEVICE AVAILABLE OR HOW THE ISSUE WAS RESOLVED, IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22099367 ↗
• MalfunctionMar 28, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, A PORTION OF THE DISPOSABLE THREADED CANNULA VALVE CAME LOOSE AND BROKE, THE BROKEN PART WAS REMOVED THROUGH ASPIRATION. THE PROCEDURE WAS COMPLETED USING THE SAME REPORTED DEVICE, IT LEAKED A LITTLE, BUT THE SURGEON DID NOT WANT TO OPEN A NEW CANNULA. THERE WAS NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21725284 ↗
• MalfunctionFeb 28, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER SURGERY AN 8.5 X 72MM CLEAR-TRAC CANNULA PORTAL WAS INSERTED ON A REUSABLE HANDLE OVER A SWITCHING STICK. IT WAS NOTICED THAT A SMALL PIECE OF THE DIAPHRAGM FROM THE CANNULA HAD BROKEN OFF, THIS WAS FLOATING IN THE SHOULDER JOINT. SURGEON RETRIEVED THE FOREIGN BODY WITH A GRASPER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21497719 ↗
• MalfunctionFeb 28, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE, THE CANNULA THREADED GREEN PLASTIC WAS BREAKING OFF INTO THE PATIENT. THE BROKEN PIECES WERE REMOVED WITH SUCTION AND GRASPER. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE AND A SURGICAL DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21494314 ↗
• MalfunctionFeb 21, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, THE CANNULA THREADED GREEN PLASTIC WAS BREAKING OFF INTO THE PATIENTS SHOULDER WHILE THE DEVICE WAS IN USE. THE PROCEDURE WAS COMPLETED CHANGING THE SURGICAL TECHNIQUE AND NOT USING CANNULA AND A DELAY OF LESS THAN 30 MINUTES WAS REPORTED. PLASTIC SHEARED WAS REMOVED WITH THE HELP OF GRASPERS AND SUCTION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21437687 ↗
• MalfunctionFeb 19, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, THE CANNULA THREADED GREEN PLASTIC WAS BREAKING OFF INTO THE PATIENTS SHOULDER WHILE THE DEVICE WAS IN USE. THE PROCEDURE WAS COMPLETED BY NOT USING THE CANNULA ANYMORE, EVEN THOUGH IT ADDED TIME TO MADE THE PORTALS SINCE IT WAS MORE DIFFICULT. THERE WAS A DELAY OF LESS THAN 30 MINUTES WAS REPORTED. PLASTIC SHEARED WAS REMOVED WITH THE HELP OF GRASPERS AND SUCTION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21413734 ↗
• MalfunctionFeb 19, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, THE CANNULA THREADED GREEN PLASTIC WAS BREAKING OFF INTO THE PATIENTS SHOULDER WHILE THE DEVICE WAS IN USE. THE PROCEDURE WAS COMPLETED BY NOT USING THE CANNULA ANYMORE, EVEN THOUGH IT ADDED TIME TO MADE THE PORTALS SINCE IT WAS MORE DIFFICULT. THERE WAS A DELAY OF LESS THAN 30 MINUTES WAS REPORTED. PLASTIC SHEARED WAS REMOVED WITH THE HELP OF GRASPERS AND SUCTION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21413717 ↗
• MalfunctionFeb 19, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, THE CANNULA THREADED GREEN PLASTIC WAS BREAKING OFF INTO THE PATIENTS SHOULDER WHILE THE DEVICE WAS IN USE. THE PROCEDURE WAS COMPLETED BY NOT USING THE CANNULA ANYMORE, EVEN THOUGH IT ADDED TIME TO MADE THE PORTALS SINCE IT WAS MORE DIFFICULT. THERE WAS A DELAY OF LESS THAN 30 MINUTES WAS REPORTED. PLASTIC SHEARED WAS REMOVED WITH THE HELP OF GRASPERS AND SUCTION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21413694 ↗
• MalfunctionDec 19, 2024Material Disintegration; Leak/Splash; Material Disintegration; Leak/Splash

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE CANNULA THREADED DISP 8.5 X 72MM HAD PARTICLES BREAKING OFF ON THE WHITE SEPTUM AND ENDED UP IN THE JOINT AND HAD SALINE TO SPURT OUT OR BACK FLOW UP THE SHAFT OF THE GREEN CANNULA AND OUT THE SEPTUM. THE PARTICLES WERE RETRIEVED FROM PATIENT. THE PROCEDURE WAS COMPLETED WITH THE SAME FAULTY DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20978461 ↗
• MalfunctionNov 20, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, A SMALL PART OF THE CANNULA SYSTEM BROKE OFF AS IT WAS INSERTED INTO THE PATIENT. THE PIECE WAS RETRIEVED FROM THE PATIENT USING TWEEZERS. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20738243 ↗
• MalfunctionNov 14, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, A SMALL PART OF THE CANNULA SYSTEM BROKE OFF AS IT WAS INSERTED INTO THE PATIENT. THE PIECE WAS RETRIEVED FROM THE PATIENT USING TWEEZERS. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20683193 ↗
• MalfunctionSep 16, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE CANNULA THREADED HAD A BROKEN MEMBRANE. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. THERE WAS A DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20224272 ↗
• MalfunctionDec 11, 2023Break; Break

  IT WAS REPORTED THAT UPON SETTING UP THE CANNULA SYSTEM FOR AN ARTHROSCOPY, IT WAS NOTICED THAT THERE WERE BITS OF PLASTIC INSIDE THE CANNULA, THERE WAS AN ISSUE WITH THE RUBBER SEAL INSIDE AND PIECES OF RUBBER WERE FALLING OUT. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18305944 ↗
• MalfunctionDec 5, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, WHEN USING THE CANNULA SYSTEM, A SMALL PIECE OF PLASTIC WAS FOUND INSIDE THE PATIENT, THE PIECE WAS RETRIEVED AND NO HARM WAS CAUSED. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A DELAY OF LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18267478 ↗
• InjuryJan 2, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE CANNULA BROKE AND IT FALL IN THE PATIENT BODY. THE BROKEN PIECE WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH 10 MINUTES DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. AFTER THE SURGERY, THE SURGEON FOUND THAT THE CONNECTION PART OF THE CAP WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16082936 ↗
• InjuryDec 22, 2022No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A SHOULDER STABILIZATION, WHEN USING THE CANNULA THREADED, IT WAS FOUND SOME PLASTIC FRAGMENTS FLOATING AROUND THE JOINT, THEY ASSUMED THAT THEY HAD DAMAGED ONE OF THE CLEAR TRAC CANNULAS WITH THE SHAVER. SOME OF THE FRAGMENTS WERE SUCKED UP AND TWO FRAGMENTS WERE REMOVED WITH A GRASPER. HOWEVER, WHEN THE CANNULAS WERE REMOVED, THEY LOOKED INTACT. NON-SIGNIFICANT DELAY WAS REPORTED, AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16035332 ↗
• MalfunctionSep 6, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN SHOULDER ARTHROSCOPY PROCEDURE, THE CANNULA BROKE VERY EASILY WHEN IMPACTING THE ANCHOR, THE SURGEON DID NOT USE THE HAMMER, SO HE APPLIED FORCE AND CAUSED THE CANNULA TO BREAK. THE INSTRUMENT BROKE OUTSIDE OF THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12431046 ↗
• InjuryApr 30, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE WHITE PLASTIC DETACHED FROM CANNULA TO THE JOIN SPACE, THEY USED A GRASPER TO REMOVE IT. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND A DELAY GREATER THAT 30 MIN. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11757945 ↗
• InjuryApr 30, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE WHITE PLASTIC DETACHED FROM CANNULA TO THE JOIN SPACE, THEY USED A GRASPER TO REMOVE IT. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND A DELAY GREATER THAT 30 MIN. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11757916 ↗
• InjuryApr 30, 2021Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY, A SMALL PIECE OF PLASTIC RUBBER OF THE THREADED CANNULA BROKE INTO THE JOINT. ALL PIECES WERE REMOVED BY TISSUE GRASPER. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11757697 ↗
• MalfunctionFeb 1, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING SHOULDER ROTATOR CUFF REPAIR SURGERY, WHILE OPENING THE THREADED CANNULA PACKAGE, THE PRODUCT HAD A FOREIGN BODY INSIDE PACKAGE. THE MALFUNCTION WAS SOLVED WITH A DELAY SHORTER THAN 30 MINUTES AND NO PATIENT HARM USING A BACK UP DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11262779 ↗
• MalfunctionFeb 1, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING SHOULDER ROTATOR CUFF REPAIR SURGERY, WHILE OPENING THE THREADED CANNULA PACKAGES, THE PRODUCT HAD A FOREIGN BODY INSIDE PACKAGE. THE MALFUNCTION WAS SOLVED WITH A DELAY SHORTER THAN 30 MINUTES AND NO PATIENT HARM USING A BACK UP DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11262688 ↗