CLEAR-TRACRecalls & reported problems across all models

We found 14 models of CLEAR-TRAC by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 74 adverse event reports in the FDA's MAUDE database, received between May 14, 2018 and Jun 2, 2026 — classified as 19 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Break” (33 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported CLEAR-TRAC problems

CLEAR-TRAC models

14 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CLEAR-TRAC 72200903

  ACCESSORIES,ARTHROSCOPIC
  29 reports
• CLEAR-TRAC 72200425

  ACCESSORIES,ARTHROSCOPIC
  10 reports
• CLEAR-TRAC 72200905

  ACCESSORIES,ARTHROSCOPIC
  9 reports
• CLEAR-TRAC 72200427

  ACCESSORIES,ARTHROSCOPIC
  6 reports
• CLEAR-TRAC 014718

  ACCESSORIES,ARTHROSCOPIC
  5 reports
• CLEAR-TRAC 72200429

  ACCESSORIES,ARTHROSCOPIC
  4 reports
• CLEAR-TRAC 014719

  ACCESSORIES,ARTHROSCOPIC
  3 reports
• CLEAR-TRAC 72200436

  ACCESSORIES,ARTHROSCOPIC
  2 reports
• CLEAR-TRAC 72200906

  ACCESSORIES,ARTHROSCOPIC
  1 report
• CLEAR-TRAC 72200907

  ACCESSORIES,ARTHROSCOPIC
  1 report
• CLEAR-TRAC 72200424

  ACCESSORIES,ARTHROSCOPIC
  1 report
• CLEAR-TRAC 72200428

  ACCESSORIES,ARTHROSCOPIC
  1 report
• CLEAR-TRAC 72200431

  ACCESSORIES,ARTHROSCOPIC
  1 report
• CLEAR-TRAC 72201634

  ACCESSORIES,ARTHROSCOPIC
  1 report

Recent CLEAR-TRAC adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Fracture

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR PROCEDURE, AFTER PLACING THE ANCHOR, IT WAS NOTICED THAT THE THREADED CANNULA HAD A 0.3*0.1 CM DEFECT ON THE INNER SURFACE. A SEARCH WAS CONDUCTED ON THE OPERATING TABLE AND INCISION DRAPES, BUT THE MISSING PIECE WAS NOT FOUND, THE SURGEON ADDITIONALLY INFORMED THAT THE DEFECT WAS TOO SMALL TO BE LOCATED WITHIN THE CAVITY, THEREFORE, IT WAS CONTINUOUSLY RINSED WITH SALINE. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED; HOWEVER, THERE WAS A NON-SIGNIFICANT SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25369134 ↗
• 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 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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