CLEAR-TRAC 72200425Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03596010597021), received between Feb 11, 2021 and Apr 5, 2026 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2026Break; Material Deformation

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR, THE CANNULA THREADED FLEX WAS FOUND TWISTED INSIDE THE STERILE PACKAGING, MAKING IT IMPOSSIBLE TO INSERT THE MANDREL. THE ENTIRE BATCH RECEIVED IN THE OPERATING ROOM APPEARED DEFECTIVE, WITH THE TWISTING VISIBLE TO THE NAKED EYE. THE SURGEON AGREED TO USE THE SAME CANNULAS TO COMPLETE THE PROCEDURE BECAUSE NO SUITABLE ALTERNATIVES WERE AVAILABLE. SIGNIFICANT DIFFICULTY WAS ENCOUNTERED WHEN INSERTING BOTH THE MANDRELS AND THE REPAIR INSTRUMENTS. AS THE INSTRUMENTS STRUCK THE WALL OF A CANNULA, ONE (1) CANNULA THREADED FLEX BROKE, AND A FRAGMENT BECAME LODGED INSIDE THE PATIENT¿S SHOULDER. THE SURGEON HAD TO LOCATE AND RETRIEVE THIS FRAGMENT. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY, AND NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24787094 ↗
• MalfunctionMar 12, 2026Material Deformation

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, TWO (2) CANNULAS THREADED FLEX WERE BENT. IT MADE THEM DIFFICULT TO USE AS THE INSTRUMENTS SLID POORLY INSIDE THEM COMPLICATING THE PLACEMENT OF ANCHORS. THE PROCEDURE WAS PERFORMED, WITH A DELAY GREATER THAN 30 MIN, USING THE SAME DEVICE. IT IS UNKNOWN IF ADDITIONAL ANESTHESIA WAS REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24581409 ↗
• MalfunctionDec 30, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE CANNULA THREADED FLEX MANDREL BROKE INSIDE THE TROCAR SLEEVE, FORCING THE SURGEON TO REPEAT THE PROCEDURE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23920493 ↗
• MalfunctionOct 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, IT WAS NOTICED THAT THE CANNULA THREADED WAS DAMAGED AND FELL INTO THE INCISION, WHICH WAS DIFFICULT TO DETECT. THE PROCEDURE/TREATMENT WAS RESUMED, USING THE SAME DEVICE. IT US UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23263028 ↗
• MalfunctionSep 24, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC CUFF SUTURING, A WHITE PLASTIC FRAGMENT OF THE RUBBER FROM THE INSIDE OF THE THREADED CANNULA, WAS FOUND IN THE JOINT. THE PIECE WAS REMOVED WITH TWEEZERS. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20297300 ↗
• MalfunctionApr 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CUFF REPAIR SURGERY, THE CANNULA CAME APART INTO PIECES. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16668496 ↗
• InjuryNov 2, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY WHEN THE CANNULA WAS USED, A DEFRAGMENTATION OF THE PART THAT DETACHES INSIDE THE PATIENT'S CAVITY OCCURRED. ALL PIECES WERE REMOVED, AND NO DAMAGE WAS CAUSED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15717953 ↗
• InjuryJul 5, 2022Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY, THE THREADED CANNULA BROKE WHEN IT WAS BEING PULLED OUT OF THE JOINT, AND AFTER BREAKING THE PRODUCT STAYED IN THE JOINT. THE NURSE HAD TO OPEN ANOTHER PRODUCT AND TO GO AGAIN INSIDE THE JOINT. IT IS UNKNOWN IF THE BROKEN PIECES WERE REMOVED FROM THE PATIENT AND IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14920502 ↗
• MalfunctionJun 2, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION FOR AN ARTHROSCOPY, NURSE FOUND A HAIR IN AN UNOPENED CANNULA PACKAGE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11923892 ↗
• InjuryFeb 11, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, WHEN INSERTING A CANNULA TO THE PATIENT, A FOREIGN MATERIAL WAS FOUND INSIDE THE PATIENT. ALL DEBRIS WERE REMOVED FROM THE PATIENT BY USING A GRASPER. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME DEVICE. NO DELAY AND NO PATIENT 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 11319367 ↗