NA 5820080021Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07613153022374), received between Oct 24, 2018 and Jul 26, 2023 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Fracture” (9 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 26, 2023Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17397009 ↗
• MalfunctionJan 10, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT THE RASP BROKE. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16134715 ↗
• MalfunctionApr 15, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE HELIOCOIDAL RASP BROKE. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14117603 ↗
• MalfunctionNov 22, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE HELIOCOIDAL RASP BROKE IN THE ATTACHMENT. IT WAS ALSO REPORTED THAT THERE WAS A TEN MINUTE DELAY AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12853652 ↗
• MalfunctionMay 28, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A MEDICAL PROCEDURE, THE METAL CUTTING RASP BROKE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11900696 ↗
• MalfunctionMay 28, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A MEDICAL PROCEDURE, THE METAL CUTTING RASP BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11900691 ↗
• MalfunctionMay 28, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A MEDICAL PROCEDURE, THE METAL CUTTING RASP BROKE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11900688 ↗
• MalfunctionApr 1, 2021Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT THE METAL CUTTING RASP BROKE. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11603661 ↗
• MalfunctionMar 12, 2021Break; Break

  IT WAS REPORTED DURING A SPINE SURGERY PROCEDURE TWO HELIOCOIDAL RASPS BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WAS A TEN MINUTE DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR THE FIRST HELIOCOIDAL RASP THAT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11473936 ↗
• MalfunctionMar 12, 2021Break; Fracture; Break; Fracture

  IT WAS REPORTED DURING A SPINE SURGERY PROCEDURE TWO HELIOCOIDAL RASPS BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WAS A TEN MINUTE DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR THE SECOND HELIOCOIDAL RASP THAT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11473922 ↗
• MalfunctionMar 5, 2021Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT TWO METAL CUTTING RASPS BROKE DURING THE SAME PROCEDURE. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS RECORD ADDRESSES ONE OF THE TWO RASPS WHICH WERE REPORTED TO HAVE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11424190 ↗
• MalfunctionMar 5, 2021Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT TWO METAL CUTTING RASPS BROKE DURING THE SAME PROCEDURE. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS RECORD ADDRESSES ONE OF THE TWO RASPS WHICH WERE REPORTED TO HAVE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11424175 ↗
• MalfunctionMar 5, 2021Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT TWO METAL CUTTING RASPS BROKE DURING THE SAME PROCEDURE. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS RECORD ADDRESSES ONE OF THE TWO RASPS WHICH WERE REPORTED TO HAVE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11424157 ↗
• MalfunctionMar 5, 2021Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT TWO METAL CUTTING RASPS BROKE DURING THE SAME PROCEDURE. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS RECORD ADDRESSES ONE OF THE TWO RASPS WHICH WERE REPORTED TO HAVE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11424120 ↗
• MalfunctionJan 11, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A MEDICAL PROCEDURE THE RASP BROKE OFF IN THE ATTACHMENT. IT WAS ALSO REPORTED THAT THERE WAS A TEN MINUTE DELAY AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11146915 ↗
• MalfunctionOct 24, 2018Break; Break

  THIS REPORT SUMMARIZES <NOE> 2 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE BROKE DURING EXTRACTION OF A COMPETITOR HIP IMPLANT, WHILE REMOVING HARD BONE CEMENT. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8001665 ↗