ACUFEX 012020Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010023469), received between Feb 13, 2020 and May 14, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY FOR A KNEE MENISCUS, THE PUNCH BASKET BROKE OFF IN THE PATIENT'S JOINT (METAL PIECE OF 0.5CM X 1.5CM). AN X-RAY WAS PERFORMED TO LOCATE THE PIECE AND AN ADDITIONAL INCISION WAS MADE ON THE PATIENT TO REMOVE IT RESULTING IN A SURGICAL DELAY OF 8 MINUTES. IT IS UNKNOWN IF A BACK-UP DEVICE WAS AVAILABLE. NO OTHER COMPLICATIONS WERE REPORTED. CURRENT PATIENT STATUS WAS REPORTED AS ¿GOOD¿.

  Patient problems: Laceration(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 11828574 ↗
• MalfunctionFeb 13, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE PUNCH BASKET BROKE INSIDE THE PATIENT. THE BROKE PIECE REMAINED IN THE PATIENT'S KNEE ALTHOUGH THE OPERATOR STRUGGLED TO RESCUE IT. PATIENT RELEASED WITH THE BROKE PART OF THE INSTRUMENT IN THE KNEE. IT IS UNKNOWN IF THERE WAS A DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. NO PATIENT INJURIES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 9706396 ↗