ACUFEX 012014Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03596010023360), received between Jan 12, 2018 and May 18, 2026 — classified as 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2026Break

  IT WAS REPORTED THAT A PUNCH BASKET BROKE. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25203757 ↗
• MalfunctionApr 18, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SET UP, IMMEDIATELY AFTER THE FIRST USE, THE DUCKBILL MOUTH CAME LOOSE. THERE WAS A BACK-UP DEVICE AVAILABLE AND NO SURGICAL DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765212 ↗
• InjuryDec 2, 2022Flaked; Difficult to Open or Close; Flaked; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A KNEE SCOPE, THE PUNCH FAILED TO PERFORMED AS EXPECTED. IT IS UNKNOWN IF THE DEVICE WOULD NOT BITE THROUGH TISSUE OR IT WAS DIFFICULT TO OPEN AND CLOSE AND WAS SHEDDING METAL. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A NON-SIGNIFICANT SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15903498 ↗
• InjuryDec 2, 2022Flaked; Difficult to Open or Close; Flaked; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A KNEE SCOPE, THE PUNCH FAILED TO PERFORMED AS EXPECTED. IT IS UNKNOWN IF THE DEVICE WOULD NOT BITE THROUGH TISSUE OR IT WAS DIFFICULT TO OPEN AND CLOSE AND WAS SHEDDING METAL. THE SHAVINGS WERE REMOVED BY SUCTION. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A NON-SIGNIFICANT SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15902613 ↗
• InjuryDec 2, 2022Flaked; Difficult to Open or Close; Flaked; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A KNEE SCOPE, THE PUNCH FAILED TO PERFORMED AS EXPECTED. IT IS UNKNOWN IF THE DEVICE WOULD NOT BITE THROUGH TISSUE OR IT WAS DIFFICULT TO OPEN AND CLOSE AND WAS SHEDDING METAL. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A NON-SIGNIFICANT SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15902601 ↗
• InjuryDec 2, 2022Flaked; Difficult to Open or Close; Flaked; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A KNEE SCOPE, THE PUNCH FAILED TO PERFORMED AS EXPECTED. IT IS UNKNOWN IF THE DEVICE WOULD NOT BITE THROUGH TISSUE OR IT WAS DIFFICULT TO OPEN AND CLOSE AND WAS SHEDDING METAL. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A NON-SIGNIFICANT SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15902471 ↗
• InjuryDec 2, 2022Flaked; Difficult to Open or Close; Flaked; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A KNEE SCOPE, THE PUNCH FAILED TO PERFORMED AS EXPECTED. IT IS UNKNOWN IF THE DEVICE WOULD NOT BITE THROUGH TISSUE OR IT WAS DIFFICULT TO OPEN AND CLOSE AND WAS SHEDDING METAL. THE SHAVINGS WERE REMOVED BY SUCTION. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A NON-SIGNIFICANT SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15902462 ↗
• InjuryDec 1, 2022Flaked; Difficult to Open or Close; Flaked; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A KNEE SCOPE, THE PUNCH FAILED TO PERFORMED AS EXPECTED. IT IS UNKNOWN IF THE DEVICE WOULD NOT BITE THROUGH TISSUE OR IT WAS DIFFICULT TO OPEN AND CLOSE AND WAS SHEDDING METAL. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A NON-SIGNIFICANT SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15899364 ↗
• MalfunctionOct 13, 2020Break; Break

  IT WAS REPORTED THAT THE PUNCH BASKET DUCKLING WAS BROKEN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 10672014 ↗
• MalfunctionJan 12, 2018Device Operates Differently Than Expected; Noise, Audible

  IT WAS REPORTED WHILE THE PUNCH IS USED IN SOFT TISSUE IT MAKES A TYPICAL SOUND WHICH IS LIKE FACING AN OBSTRUCTION WHILE CUTTING IN THE SHAFT. THE SURGEON SAID THAT IT WAS AN UNUSUAL SOUND AND CAUSED INCONVENIENCE WHILE OPERATING. THERE WAS NO BACK UP AVAILABLE.

  Patient problems: No Information

  MAUDE report 7185122 ↗