CLEAR-TRAC 72200427Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010597045), received between Apr 2, 2019 and Feb 12, 2024 — classified as 1 injury, 5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2024Break; Manufacturing, Packaging or Shipping Problem; Break; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT, DURING SET UP FOR A ROTATOR CUFF REPAIR, A PIECE OF PLASTIC WAS PRESENT IN THE CLEAR-TRAC FLEXIBLE CANNULA AND PREVENTED THE CHUCK FROM PASSING THROUGH. NO 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 18692140 ↗
• InjuryMar 25, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, A SMALL PORTION OF THE CANNULA'S DIAPHRAGM WAS TORN AND FOUND INSIDE THE JOINT SPACE. THE FRAGMENT WAS RETRIEVED WITH ARTHROSCOPIC GRASPERS, AND A SMITH AND NEPHEW BACK UP CANNULA WAS USED TO FINISH THE CASE. THERE WAS A DELAY OF LESS THAN OR EQUAL TO 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 11572278 ↗
• MalfunctionJul 31, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SETUP WHEN THE PACKAGE WAS OPENED IT WAS FOUND THAT THE TIP OF THE CANNULA WAS CHIPPED. THERE WAS BACKUP DEVICE AVAILABLE, NO DELAY OR PATIENT INJURIES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10350851 ↗
• MalfunctionJul 17, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SURGERY, DISTAL PART OF NEW PRODUCT WAS SLIGHTLY BROKEN OR DISTORTED. NO PATIENT INJURIES REPORTED, NO SIGNIFICANT DELAY REPORTED. NO BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8800144 ↗
• MalfunctionMay 27, 2019Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPIC STABILIZATION, THE CANNULA BROKE WHILE WAS IN PATIENT. PIECES TAKEN OUT OF PATIENT. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE BEFORE TO KNOW THAT IT WAS BROKEN, WITH NO SIGNIFICANT DELAY AND NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8643288 ↗
• MalfunctionApr 2, 2019Break

  IT WAS REPORTED THAT DURING SURGERY THE OBTURATOR WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8475268 ↗