ACUFEX 012045Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010023995), received between Dec 24, 2018 and Jan 6, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2025Break; Break

  IT WAS REPORTED THAT DURING A ACL PROCEDURE, THE CLAMP ON THE PUNCH BASKET BROKE. THE BROKEN FRAGMENTS WERE REMOVED FROM THE PATIENT USING ANOTHER CLAMP. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21079708 ↗
• MalfunctionAug 23, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT, DURING A PROCEDURE, TWO (2) BASKET PUNCH DEVICES FAILED. THE CLAMP OF THE FIRST BASKET PUNCH WAS NOT CUTTING CORRECTLY. THE FAILURE OF THE SECOND BASKET PUNCH REPORTED IS UNKNOWN. SURGERY WAS COMPLETED AFTER A SIGNIFICANT DELAY (>30-MINUTES) USING A BACK-UP DEVICE INSTEAD. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17606769 ↗
• InjuryMar 24, 2023Break; Break

  IT WAS REPORTED THAT DURING A MENISCECTOMY PROCEDURE, WHEN THE SURGEON WAS USING THE BASKET PUNCH, THE BOTTOM JAW BROKE OFF IN THE PATIENT. THE BROKEN PIECE THAT BROKE OFF LODGED NEAR THE POPLITEAL TENDON BENEATH THE TIBIA AND COULD NOT BE RETRIEVED. THE PROCEDURE WAS COMPLETED WITH A DELAY GREATER THAN 30 MINUTES WITH A DIFFERENT SURGICAL TECHNIQUE. THE CURRENT PATIENT STATUS IS FINE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16616309 ↗
• MalfunctionMar 23, 2021Break; Break

  IT WAS REPORTED THAT THE LOWER JAW WAS BROKEN IN THE BASKET PUNCH, DUCKLING UPBITER. NO CASE REPORTED; THEREFORE THERE WAS NO PATIENT INVOLVED. 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 11555606 ↗
• MalfunctionDec 24, 2018Break

  IT WAS REPORTED THAT DURING A MENISCAL RESECTION THE BOTTOM JAW BROKE. ALL PIECES WERE REMOVED SUCCESSFULLY. IT IS UNKNOWN IF A BACKUP WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED. THERE WAS NO SIGNIFICANT DELAY AND NO PATIENT INJURY OR OTHER COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8194068 ↗