NA 310.65Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982186850), received between Nov 4, 2020 and Nov 24, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2025Break; Break

  VOLUNTARY REPORT RECEIVED (B)(4). IT WAS REPORTED DURING A CASE, THE SURGEON NOTICED DRILL BIT WAS FLAKING SMALL PIECES OF METAL. THIS OBSERVATION WAS NOTICED PRIOR TO DRILL BIT ENTERING THE PATIENT. THE DRILL BIT WAS REMOVED FROM THE FIELD AND REPLACED WITH A NEW BIT FROM THE SAME SET. THE DEVICE WAS NOT AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23637139 ↗
• MalfunctionOct 24, 2025Break; Break

  IT WAS REPORTED ON (B)(4) 2025, DURING A CASE, THE SURGEON NOTICED THE DRILL BIT WAS FLAKING SMALL PIECES OF METAL. THIS WAS OBSERVED PRIOR TO DRILL BIT ENTERING THE PATIENT. THE DRILL BIT WAS REMOVED FROM THE FIELD AND REPLACED WITH A NEW DRILL BIT FROM THE SAME SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23380696 ↗
• MalfunctionJul 24, 2023Failure to Cut; Material Deformation; Failure to Cut; Material Deformation

  DEVICE REPORT FROM CHILE REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT REDUCTION AND OSTEOSYNTHESIS WITH CANNULATED SCREWS FOR A TRIPLANAR FRACTURE OF THE LEFT ANKLE. DURING THE PROCEDURE, IT WAS DISCOVERED THAT THE DRILL BITS IN QUESTION WERE BLUNT AND WOULD NOT DRILL AS INTENDED. IT WAS ATTEMPTED TO DRILL MULTIPLE TIMES AND THE GUIDE WIRE BROKE, REMAINING INSIDE OF THE PATIENT. ANOTHER SET OF DRILL BITS WERE REQUESTED TO COMPLETE THE PROCEDURE, HOWEVER THEY WERE WORN AND DULL AS WELL. THE PROCEDURE WAS DELAYED BY APPROXIMATELY 20 MINUTES BECAUSE OF THIS EVENT. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS FOR A 3.2MM CANNULATED DRILL BIT/QC 170MM. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17380386 ↗
• MalfunctionJul 24, 2023Failure to Cut; Material Deformation; Failure to Cut; Material Deformation

  DEVICE REPORT FROM CHILE REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2023, THE PATIENT UNDERWENT REDUCTION AND OSTEOSYNTHESIS WITH CANNULATED SCREWS FOR A TRIPLANAR FRACTURE OF THE LEFT ANKLE. DURING THE PROCEDURE, IT WAS DISCOVERED THAT THE DRILL BITS IN QUESTION WERE BLUNT AND WOULD NOT DRILL AS INTENDED. IT WAS ATTEMPTED TO DRILL MULTIPLE TIMES AND THE GUIDE WIRE BROKE, REMAINING INSIDE OF THE PATIENT. ANOTHER SET OF DRILL BITS WERE REQUESTED TO COMPLETE THE PROCEDURE, HOWEVER THEY WERE WORN AND DULL AS WELL. THE PROCEDURE WAS DELAYED BY APPROXIMATELY 20 MINUTES BECAUSE OF THIS EVENT. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS FOR A 3.2MM CANNULATED DRILL BIT/QC 170MM. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17380234 ↗
• MalfunctionJul 18, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE CANNULATED 3.2 DRILL BIT WAS DULL DURING SURGERY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 3.2MM CANNULATED DRILL BIT/QC 170MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17343757 ↗
• MalfunctionMay 24, 2023Break; Break

  DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN MAY 2023, THE DRILL BIT BROKE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR A 3.2MM CANNULATED DRILL BIT/QC 170MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16992347 ↗
• MalfunctionJan 11, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLUMBIA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRILL BIT WAS BLUNT. THERE WAS NO OTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 3.2MM CANNULATED DRILL BIT /QC 170MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16138536 ↗
• MalfunctionJul 5, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE DRILL BIT WAS FOUND TO BE DULL. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR A 3.2MM CANNULATED DRILL BIT/QC 170MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14916761 ↗
• MalfunctionNov 4, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE DRILL BIT WAS DAMAGED AND BROKEN. THIS REPORT IS FOR ONE (1) 3.2MM CANNULATED DRILL BIT/QC 170MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10785301 ↗