NA 03.033.005Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982270962), received between May 6, 2021 and Jan 6, 2026 — classified as 6 malfunctions.

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

• MalfunctionJan 6, 2026Break

  IT WAS REPORTED ON(B)(6) 2025 THAT THE REPORTER WERE USING THE FRN SYSTEM. WHILE ATTEMPTING TO OPEN THE PROXIMAL SEGMENT ON THE PIRIFORMIS FOSSA WITH THE 14MM OPENING DRILL, IT BROKE AT THE CONNECTION. THE DRILL BIT WAS REMOVED AND ANOTHER SET WAS OPENED TO GET A 2ND DRILL BIT. THERE WAS VERY LITTLE FORCE PUT ON THE DRILL FROM THE SURGEON. NO FRAGMENTS LEFT IN THE PATIENT. CASE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973333 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT THE FRN SYSTEM WAS BEING USED IN A PROCEDURE. WHILE ATTEMPTING TO OPEN THE PROXIMAL SEGMENT ON THE PIRIFORMIS FOSSA WITH THE 14MM OPENING DRILL, THE DRILL BIT BROKE AT THE CONNECTION. THE DRILL BIT WAS REMOVED AND ANOTHER SET WAS OPENED. THEY TRIED AGAIN AND THE NEW DRILL BIT BROKE AGAIN AT THE CONNECTION WITH THE COMPETITOR HAND PIECE. NO FRAGMENTS WERE LEFT IN THE PATIENT. THEY ENDED UP USING A 13MM DRILL BIT FROM THE RAFN SET TO EVENTUALLY OPEN THE CANAL. CASE ENDED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23292266 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT THE FRN SYSTEM WAS BEING USED IN A PROCEDURE. WHILE ATTEMPTING TO OPEN THE PROXIMAL SEGMENT ON THE PIRIFORMIS FOSSA WITH THE 14 MM OPENING DRILL, THE DRILL BIT BROKE AT THE CONNECTION. THE DRILL BIT WAS REMOVED AND ANOTHER SET WAS OPENED. THEY TRIED AGAIN AND THE NEW DRILL BIT BROKE AGAIN AT THE CONNECTION WITH THE COMPETITOR HAND PIECE. NO FRAGMENTS WERE LEFT IN THE PATIENT. THEY ENDED UP USING A 13 MM DRILL BIT FROM THE RAFN SET TO EVENTUALLY OPEN THE CANAL. CASE ENDED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23291435 ↗
• MalfunctionJun 28, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE A 14MM CANNULATED DRILL BIT BROKE AT THE BASE WHILE TRYING TO MEDIALIZE WITH OPENING DRILL, NO FRAGMENTS WERE GENERATED AND NOTHING WAS LEFT INSIDE THE PATIENT. THEN AFTER INSERTING THE NAIL, THE 4.5/6.5 STEPPED DRILL BIT LARGE QC/485 BROKE OFF AT THE TIP AFTER COMING INTO CONTACT WITH A LARGE POINT TO POINT CLAMP (WEBER CLAMP). THE BROKEN PIECE WAS LEFT INSIDE THE BONE AS IT WAS DEEMED TOO DIFFICULT TO REMOVE. SURGERY COMPLETED SUCCESSFULLY. NO OTHER PATIENT INFO AT THIS TIME. THIS REPORT IS FOR ONE (1) 14MM CANNULATED DRILL BIT . THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14841914 ↗
• MalfunctionMay 6, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE THE REAMER TIP SHAVED OFF AND AIMING ARM CLIP BROKE OFF. IT IS UNKNOWN IF THERE WERE FRAGMENTS GENERATED. IT WAS REPORTED THAT THERE WAS A SURGERY DELAY. IT IS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) 14MM CANNULATED DRILL BIT. THIS REPORT IS 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11784250 ↗
• MalfunctionMay 6, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE THE REAMER TIP SHAVED OFF AND AIMING ARM CLIP BROKE OFF. IT IS UNKNOWN IF THERE WERE FRAGMENTS GENERATED. IT WAS REPORTED THAT THERE WAS A SURGERY DELAY. IT IS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) 14MM CANNULATED DRILL BIT. THIS REPORT IS 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11784249 ↗