CLEAR-TRAC 72200905Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010595133), received between May 28, 2019 and Mar 25, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING A ROTATOR CUFF PROCEDURE, THE CLEARTRAC CANNULA PACKAGE WAS RECEIVED ALREADY OPEN. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MINUTES, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690361 ↗
• MalfunctionFeb 5, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, PLASTIC PIECES OF THE CLEARTRAC THREADED CANNULA WERE IDENTIFIED FLOATING AROUND. CLEAR PLASTIC FROM THE TIP AND WHITE PLASTIC FROM THE CANNULA WERE IDENTIFIED. IT IS UNCLEAR HOW THE PROCEDURE WAS COMPLETED, AND IT IS UNKNOWN WHETHER THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268366 ↗
• MalfunctionFeb 4, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, PLASTIC PIECES OF THE CLEARTRAC THREADED CANNULA WERE IDENTIFIED FLOATING AROUND. CLEAR PLASTIC FROM THE TIP AND WHITE PLASTIC FROM THE CANNULA WERE IDENTIFIED. IT IS UNCLEAR HOW THE PROCEDURE WAS COMPLETED, AND IT IS UNKNOWN WHETHER THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24264907 ↗
• MalfunctionAug 11, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING SET UP FOR A KNEE ARTHROSCOPY, THE CLEARTRAC CANNULA HAD BROKEN PACKAGING AND THEREFORE, WAS NOT STERILE. THERE WAS A SMITH AND NEPHEW BACK-UP DEVICE AVAILABLE AND NO DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22771564 ↗
• InjuryFeb 18, 2021Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE THE LITTLE PORTIONS OF THE CANNULA TRIPLE SEAL WERE BREAKING OFF WHEN INTRODUCING THE INSTRUMENTS INTO THE CANNULA. THE DEVICE BREAK INSIDE THE PATIENT, THE PIECES WERE REMOVED USING GRASPER AND SHAVER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A 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 11342864 ↗
• MalfunctionOct 11, 2020Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE CANNULA BROKE. IT DID NOT CONNECT INTO THE EQUIPMENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR 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; No Known Impact Or Consequence To Patient

  MAUDE report 10660173 ↗
• MalfunctionAug 10, 2020Break; Break

  IT WAS REPORTED THAT DURING SHOULDER SURGERY, A 7.0 MM CANNULA CLEARTRAC WAS OPENED AND BEFORE USING IT, IT WAS NOTICED THAT THE RUBBER AROUND THE TIP WAS BROKEN. A S+N BACKUP WAS USED TO COMPLETED THE PROCEDURE. THERE WAS NO DELAY AND NO PATIENT INJURY OR 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 Known Impact Or Consequence To Patient

  MAUDE report 10384081 ↗
• MalfunctionFeb 20, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, THE CANNULA HAD SMALL PIECES OF PLASTIC. THIS DEVICE WAS USED IN THE PATIENT AND THE PLASTIC PIECE FELL OFF INTO THE PATIENT BUT IT WAS RETRIEVED FROM. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE WITH NO DELAY OR PATIENT INJURY REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 9734899 ↗
• MalfunctionMay 28, 2019Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE CANNULA HAD BEEN BENT. A BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE , A DELAY GREATER THAN 30 MINUTES WAS REPORTED. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8647039 ↗