QUADTRAC 72205580Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556818282), received between Mar 13, 2025 and May 25, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 25, 2026Flaked

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, A QUADTRAC BLADE WAS CHIPPED, NOT USABLE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. ADDITIONAL ANESTHESIA WAS NOT REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25271466 ↗
• MalfunctionFeb 10, 2026Failure to Cut; Material Deformation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BLADES ON THE QUADTRAC DISPOSABLE KIT WERE DAMAGED, AS THE SURGEON ATTEMPTED TO HARVEST THE GRAFT, THE BLADES FOLDED AND WARPED, AND DID NOT MAKE PRECISE CUTS, THEY WERE NOT EVEN OR SMOOTH. THE UNEVEN CUTS THAT RESULTED FROM THE DAMAGED BLADES REQUIRED THE SURGEON TO SPEND ADDITIONAL TIME RESHAPING THE GRAFT AFTER THE HARVEST. THE PATIENT WAS NOT EXPOSED TO ADDITIONAL ANESTHESIA. THE PROCEDURE WAS RESUMED, WITH A SURGICAL DELAY GREATER THAN 30 MINUTES USING A NORMAL BLADE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24303491 ↗
• MalfunctionOct 17, 2025Delivered as Unsterile Product; Component Missing; Delivered as Unsterile Product; Component Missing

  IT WAS REPORTED THAT, WHEN THE QUADTRAC DISPOSABLE KIT WAS OPENED, THE STERILE PACKAGING HAD ALREADY BEEN OPENED AND WAS MISSING ALMOST ALL PARTS. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23320085 ↗
• MalfunctionMar 13, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING SET UP, THE PACKAGING FILM ON THE QUADTRAC DISPOSABLE KIT WAS NOT PERFECTLY ADHERED TO THE ENTIRE SURFACE OF THE PACKAGE. THERE WAS A S+N BACK UP DEVICE AVAILABLE. THERE WAS NO SURGICAL DELAY REPORTED AND THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21594254 ↗