ACUFEX 012013Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 03596010023339), received between Dec 3, 2019 and Apr 17, 2026 — classified as 8 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Break

  IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, A PUNCH BASKET DUCKBILL BROKE INTRAOPERATIVELY. NO PARTS REMAINED INSIDE THE PATIENT AND THE JOINT WAS NOT DAMAGED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24918601 ↗
• MalfunctionDec 26, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ACL SURGERY, A BASKET PUNCH DUCKBILL BROKE WHEN INSERTED TO PERFORM THE MENISCECTOMY. THE BROKEN PIECE WAS REMOVED WITH TWEEZERS. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23897784 ↗
• InjuryNov 19, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE DISTAL END OF ONE (1) PUNCH BASKET DUCKBILL BROKE OFF. THE DETACHED PORTION REMAINED LOOSE WITHIN THE JOINT; THEREFORE, A MINI POSTERO-MEDIAL OPEN ACCESS TO THE KNEE WAS NECESSARY FOR THE REMOVAL OF THE METAL FRAGMENT. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. THERE WAS AN UNSPECIFIED DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23598622 ↗
• MalfunctionOct 23, 2025Break; Break

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, THE STRAIGHT DUCKBILL BROKE, BUT NOTHING BROKE INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23367402 ↗
• MalfunctionJul 15, 2024Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE BASKET PUNCH CLAMP BROKE. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE. NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19741434 ↗
• MalfunctionMay 9, 2024Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, WHEN USING THE PRODUCT TO REGULARIZE THE MENISCUS, THE CLAMP OF THE DUCKBILL BASKET PUNCH BROKE AND WOULD NOT OPEN ANYMORE. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19279812 ↗
• MalfunctionMar 25, 2024Break; Break

  IT WAS REPORTED THAT DURING AN LCA PROCEDURE THE CLAMP OF THE PUNCH BASKET WAS BROKEN, THERE WAS NO BREAKING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18969793 ↗
• MalfunctionFeb 7, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN THE PROCEDURE WAS FINISHING THE SURGEON USED THE BASKET PUNCH AND IT BROKE. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18664378 ↗
• MalfunctionFeb 7, 2024Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE CLAMP OF THE PUNCH BASKET BROKE WHEN THE USER FORCED IT TO ENTER THE CAVITY. THERE WAS NO DAMAGE TO THE PATIENT'S HEALTH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING THE SAME FAULTY DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18663829 ↗
• MalfunctionJan 3, 2024Break; Break

  IT WAS REPORTED THAT DURING A RIGHT KNEE ARTHROSCOPY, THE HEAD OF THE STRAIGHT BASKET PUNCH BROKE IN TWO PIECES. THE VISIBLE PARTS WERE RETRIEVED FROM THE PATIENT. AN X-RAY WAS REQUESTED TO CONFIRM THERE WERE NO PARTS LEFT IN THE WOUND AND IT WAS CLEARED. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18436504 ↗
• MalfunctionDec 5, 2023Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE BASKET PUNCH CLAMP BROKE AND WAS REMOVED FROM THE PATIENT WITH A KELLY CLAMP. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18267459 ↗
• MalfunctionNov 10, 2023Break; Break

  IT WAS REPORTED THAT DURING A LCA RECONSTRUCTION, A BASKET PUNCH DUCKBILL BROKE OUTSIDE THE PATIENT. SURGERY CONTINUED WITHOUT ANY DELAY WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18112205 ↗
• MalfunctionAug 29, 2023Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BASKET PUNCH BROKE DURING USE. ALL THE BROKEN PIECES WERE RETRIEVED FORM THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING THE SAME DEVICE. NO DAMAGE WAS CAUSED TO THE PATIENT'S HEALTH CONDITION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17646385 ↗
• MalfunctionMay 19, 2023Break; Break

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE, THE BASKET PUNCH TWEEZERS BROKE WHEN THE DOCTOR WENT TO FIX THE MENISCUS. IT IS UNKNOWN HOW WAS THE PROCEDURE COMPLETED. NO SURGICAL DELAY NOR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16964946 ↗
• MalfunctionJan 9, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE USING A BASKET PUNCH DUCKBILL, WHEN THE DOCTOR BIT THE MENISCUS, THE CLAMP BROKE BUT DID NOT RELEASE ANY PART ON THE KNEE, WHEN THE CLAMP WAS REMOVED FROM THE KNEE, IT WAS VERIFIED THAT THE CLAMP WAS BROKEN AND THE PART THAT BROKE FELL TO THE GROUND. 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 16121799 ↗
• 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 15902532 ↗
• 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 15902378 ↗
• 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 15902356 ↗
• 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 15902335 ↗
• 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 15900174 ↗
• InjuryNov 9, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE OPENING PART OF THE DUCKBILL BASKET PUNCH BROKE. SURGERY WAS COMPLETED WITHOUT ANY DELAY, USING A BACK-UP DEVICE INSTEAD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15763499 ↗
• InjuryApr 18, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, WHILE THE SURGEON WAS TRYING TO REMOVE A PIECE OF THE MENISCUS, THE BASKET PUNCH WAS INTRODUCED BUT THE JAW OF THE CLAMP FRACTURED INSIDE THE INCISION. THE PROCEDURE WAS COMPLETED WITH 15 MINUTES OF DELAY. THE X-RAYS WERE EXECUTED AND NO PIECE WAS FOUND INSIDE OF THE PATIENT, THE BROKEN PIECE WAS VACUUMED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14138953 ↗
• MalfunctionApr 1, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, IT WAS NOTICED THAT THE STRAIGHT DUCKBILL FORCEPS HAD A BROKEN TIP. IT IS UNKNOWN HOW WAS THE PROCEDURE COMPLETED. NO DAMAGE CAUSED. PATIENT'S HEALTH CONDITION IS STABLE. NO DELAY WAS REPORTED AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13983228 ↗
• MalfunctionMar 10, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, IT WAS NOTICED THAT THE CLAMP OF THE 'PUNCH BASKET' WAS BROKEN. HOWEVER, IT DID NOT BROKE INSIDE THE PATIENT. IT IS UNKNOWN IF A BACKUP DEVICE WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13726364 ↗
• MalfunctionDec 3, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THE DEVICE BROKE OFF, ALL THE BROKEN PIECES WERE REMOVED BY THE DOCTOR. NO PATIENT INJURIES OR DELAY REPORTED. BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. 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 9406237 ↗