ACUFEX 72201733Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010608246), received between Jun 11, 2018 and May 17, 2021 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 17, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, WHILE RASPING THE APERTURE OF THE FEMORAL TUNNEL, THE TIP OF THE RASP BROKE OFF INTO THE PATIENT. ALL PIECES WERE REMOVED FROM PATIENT. A CHANGE IN THE SURGICAL TECHNIQUE WAS PERFORMED BY THE SURGEON. NO DELAY AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11838141 ↗
• InjuryNov 20, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ACL WHEN USING THE RASP THE TIP BROKE OFF WHILE RAPING THE ACL TIBIAL TUNNEL, THE BROKEN END WAS EASILY REMOVED. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE AND NO SIGNIFICANT DELAY OR FURTHER 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 Information

  MAUDE report 10879071 ↗
• InjurySep 9, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE TIP OF THE RASP 5MM HALF ROUND BROKE OFF INSIDE THE PATIENT'S KNEE. THE PIECE WAS SUCCESSFULLY REMOVED ARTHROSCOPICALLY. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO SIGNIFICANT DELAY AND NO PATIENT 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 Information

  MAUDE report 10511965 ↗
• MalfunctionApr 11, 2019Break

  IT WAS REPORTED THAT THE DEVICE BROKE WHILE RASPING THE BONE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED, NO BACK-UP DEVICE AVAILABLE, NO SIGNIFICANT DELAY. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8503582 ↗
• MalfunctionJun 11, 2018Break

  IT WAS REPORTED THAT DURING THE SURGERY THE SHAFT OF RASP BROKE, ALL PIECES WERE REMOVED FROM THE PATIENT'S ANATOMY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7589811 ↗