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CLEAR-TRAC 014719Recalls & reported problems

Smith & Nephew, Inc. · CLEAR-TRAC THREADED CANNULA WITH OBTURATOR 5 MM X 76 MM, LATEX FREE, BOX OF 10 · Class 1

All models of CLEAR-TRAC (14)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010026194), received between Jun 9, 2020 and May 6, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Component Missing” (1 report).

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

Device problems

  • Component Missing1
  • Detachment of Device or Device Component1
  • Material Separation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE CLEAR-TRAC CANNULA'S CAP CAME OFF AND FELL TO THE FLOOR. THE PROCEDURE WAS COMPLETED WITH A BACK-UP COMPETITOR DEVICE. NO DELAY WAS REPORTED, AND NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11787699 ↗
  • MalfunctionJan 21, 2021Component Missing; Component Missing

    IT WAS REPORTED THAT DURING SET-UP. THE CL-TR THIRD CANN 5MM/76MM LTX FREE (10) B HAD ONE OBTURATOR MISSING FROM THE PACKAGE. INSTEAD, TWO TROCARS WERE PACKED. THE PROCEDURE WAS SUCCESSFULLY 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

    MAUDE report 11208349 ↗
  • MalfunctionJun 9, 2020Material Separation; Material Separation

    IT WAS REPORTED THAT DURING SET UP IN AN ARTHROSCOPIC SURGERY, WHEN THE CUSTOMER OPENED THE PACKAGE OF THE "CLEAR-TRAC CANNULA THREADED 5X76MM", IT WAS FOUND THAT THE TIP OF THE DEVICE WAS ALREADY CHIPPED. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO PROCEDURAL DELAY AND NO PATIENT INJURIES 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 10135996 ↗

Other ACCESSORIES,ARTHROSCOPIC devices

All ACCESSORIES,ARTHROSCOPIC devices →

Sources and updates

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