CLEAR-TRAC 72200429Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010597069), received between Oct 26, 2022 and Oct 29, 2024 — classified as 1 injury, 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2024Break; Break

  IT WAS REPORTED THAT DURING AN SHOULDER PROCEDURE, A 0.5MM PIECE OF THE DISTAL TIP OF THE CLEAR-TRAC CANNULA 5.5MM BROKE WHEN INTRODUCE IN THE PATIENT. THE PIECE COULD NOT BE FOUND WITHIN THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20561690 ↗
• MalfunctionAug 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, A WHITE PART, POSSIBLY PART OF THE CANNULA DEVICE, FELL INTO THE PATIENT'S BODY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17592598 ↗
• MalfunctionJan 26, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, IT WAS NOT POSSIBLE TO REMOVE THE OBTURATOR FROM THE CANNULA. THE CUSTOMER REMOVED THE DEVICE, BUT THE OBTURATOR BROKE IN THE CANNULA. THIS PROBLEM OCCURRED OUTSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16247522 ↗
• MalfunctionOct 26, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, IT WAS NOT POSSIBLE TO REMOVE THE OBTURATOR FROM THE CANNULA, THE CUSTOMER REMOVED IT FORCIBLY, BUT THE OBTURATOR WAS BROKEN IN THE CANNULA. THE PROBLEM OCCURRED OUTSIDE THE PATIENT. SURGERY WAS COMPLETED WITHOUT DELAY, USING A BACK-UP DEVICE INSTEAD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15677443 ↗