ACUFEX 012044Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 03596010023964), received between Nov 1, 2018 and Mar 18, 2025 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC PROCEDURE FOR A BIOABSORBABLE INSTABILITY SHOULDER, THE BASKET PUNCH FORCEPS BROKE OFF INSIDE THE PATIENT'S JOINT. THE SURGEON REMOVED THE TWO FRAGMENTS FROM INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY, BUT IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21634475 ↗
• MalfunctionJan 30, 2024Break; Break

  IT WAS REPORTED THAT DURING ACL PROCEDURE, THE BASKET PUNCH´S CLAMP BROKE WHILE CUTTING. 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 18610461 ↗
• MalfunctionAug 31, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL, WHEN A PUNCH BASKET WAS USING TO GRAB THE MENISCUS, ITS TIP BROKE. THE BROKEN TIP WAS REMOVED FROM THE PATIENT USING GRASPER TWEEZERS. SURGERY CONTINUED WITHOUT DELAY WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17666089 ↗
• MalfunctionAug 21, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL, A PUNCH BASKET WAS MAKING A NOISE; IT WAS THEN NOTICED THAT THE ROD THAT MAKES THE MOUTH OF THE DEVICE OPEN AND CLOSE WAS BROKEN. SURGERY CONTINUED WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17592465 ↗
• MalfunctionApr 26, 2023Break; Break

  IT WAS REPORTED THAT DURING ARTHROSCOPY, WHEN CLAMPING THE MENISCUS THE CLAMP OF THE BASKET PUNCH BROKE. NO SURGICAL DELAY WAS REPORTED AND IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16818121 ↗
• MalfunctionAug 18, 2022Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY PROCEDURE, WHILE THE BASKET PUNCH WAS OUTSIDE THE PATIENT THE TOP JAW OF THE BITER PIECE BROKE OFF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15253448 ↗
• 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 Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10671964 ↗
• InjuryJul 7, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A MENISCECTOMY SURGERY THE PUNCHES BUSKET IS OUT OF ORDER, THE MECHANISM IS DISASSEMBLED. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING A COMPETITOR DEVICE. NO OTHER COMPLICATIONS 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 10242117 ↗
• MalfunctionApr 13, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A LCA SURGERY, THE PUNCH BASKET DUCKLING BROKE INSIDE THE PATIENT. THE PIECES WERE REMOVED FROM THE PATIENT ARTICULATION. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9955100 ↗
• MalfunctionMay 15, 2019Break; Malposition of Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE SURGERY THE TOOL SHAFT WAS OFFSET. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES. ADDITIONAL INFORMATION STATES THAT DEVICE BROKE DOWN INSIDE THE PATIENT, THERE WERE NO SEPARATED PARTS (THE MECHANISM WAS WEDGED).

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8612218 ↗
• MalfunctionMay 15, 2019Loss of Power; Failure to Align

  IT WAS REPORTED THAT DURING THE SURGERY THE TOOL SHAFT WAS OFFSET. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES. ADDITIONAL INFORMATION STATES THAT DEVICE BROKE DOWN INSIDE THE PATIENT, THERE WERE NO SEPARATED PARTS (THE MECHANISM WAS WEDGED).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8612006 ↗
• MalfunctionFeb 6, 2019Component Missing; Noise, Audible

  IT WAS REPORTED THAT WHEN DR. (B)(6) WAS PERFORMING ACL SURGERY AND HE WAS GOING TO USE THE DUCKLING STRAIGHT PUNCH BUT WHEN HE OPENED AND USED FOR THE PROCEDURE HE HEARD A SMALL CREEK SOUND AT THE END OF THE BITE. THE SMOOTH BITE OF THE PUNCH WAS MISSING. A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8312969 ↗
• MalfunctionNov 1, 2018Material Fragmentation

  IT WAS REPORTED THAT DURING THE CASE THE UNIT BROKE INTO THE PATIENT AND BROKEN PIECES WERE REMOVED ARTHROSCOPICALLY FROM THE PATIENT. THERE WAS A SIGNIFICANT DELAY GRATER THAT 30 MINUTES. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURIES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8029005 ↗