NA 03.114.007Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886982073013), received between Nov 14, 2022 and Dec 30, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (11 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THE DRILL BITS WERE DULL WHEN DRILLING THE CHANNEL. ANOTHER DRILL BIT WAS USED TO COMPLETE THE PROCEDURE WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23921660 ↗
• MalfunctionApr 24, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THE 1.1 DRILL BIT DID NOT HAVE ENOUGH CUTTING POWER AND REQUIRED EXCESSIVE FORCE TO WORK. THIS HAPPENED WHEN THE EQUIPMENT WAS OPENED.

  Patient problems: Insufficient Information

  MAUDE report 21902775 ↗
• MalfunctionMay 3, 2024Failure to Cut; Material Deformation; Failure to Cut; Material Deformation

  IT WAS REPORTED DURING A SURGERY ON (B)(6) 2024, THE DRILL BITS TWISTED DURING THE PROCEDURE AND HAD NO EDGE. SURGERY WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN SURGICAL DELAY. THIS REPORT IS FOR ONE 1.1MM DRILL BIT/MQC/75MM FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19239960 ↗
• MalfunctionMay 3, 2024Failure to Cut; Material Deformation; Failure to Cut; Material Deformation

  IT WAS REPORTED DURING A SURGERY ON (B)(6) 2024, THE DRILL BITS TWISTED DURING THE PROCEDURE AND HAD NO EDGE. SURGERY WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN SURGICAL DELAY. THIS REPORT IS FOR ONE 1.1MM DRILL BIT/MQC/75MM FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19239844 ↗
• MalfunctionDec 1, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, THE DRILL BITS IN QUESTION WERE FOUND TO BE DULL AND WOULD NOT CUT AS INTENDED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 10 MINUTES. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.1MM DRILL BIT/MQC/75MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18246179 ↗
• MalfunctionDec 1, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, THE DRILL BITS IN QUESTION WERE FOUND TO BE DULL AND WOULD NOT CUT AS INTENDED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 10 MINUTES. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.1MM DRILL BIT/MQC/75MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18246178 ↗
• MalfunctionNov 20, 2023Failure to Cut; Material Deformation; Failure to Cut; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE DRILL BIT 1.1 L75/61 2 ARIST CUTTING DRILL BITS TWISTED SPECIALIST NON-CONFORMING. DRILL BIT 1.0 L46/34, BROKEN DRILL BITS, SPECIALIST NON-CONFORMING GUIDE DRILL BIT 1.3/1.0, GUIDE COMES IN TWISTED SYSTEM BY SIDE 1.0, DOES NOT PASS DRILL BIT 1.0. PROLONGATION OF SURGICAL TIMES. THIS REPORT IS FOR ONE (1) 1.1MM DRILL BIT/MQC/75MM. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18173201 ↗
• MalfunctionMay 22, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, BOTH Ø1.1 BITS FROM THE 1.5 SYSTEM WERE FOUND DAMAGED WITH NO CUTTING EDGE. NO PATIENT IMPACT WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.1MM DRILL BIT/MQC/75MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16974753 ↗
• MalfunctionMay 22, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2023, BOTH Ø1.1 BITS FROM THE 1.5 SYSTEM WERE FOUND DAMAGED WITH NO CUTTING EDGE. NO PATIENT IMPACT WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.1MM DRILL BIT/MQC/75MM. THIS IS REPORT 1 OF 2 FOR (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16974748 ↗
• MalfunctionMay 22, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS DISCOVERED ON (B)(6) 2023 THAT THE DRILL BIT IN QUESTION WOULD NOT PROPERLY ANCHOR INTO THE MOTOR ADAPTER. THERE WAS NO REPORTED PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.1MM DRILL BIT/MQC/75MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16973378 ↗
• MalfunctionFeb 13, 2023Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE 1.1 DRILL BIT IN QUESTION FROM THE HAN LCP SYSTEM SPLIT DURING USE. THE PROCEDURE WAS COMPLETED USING ANOTHER DRILL BIT OF THE SAME TYPE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.1MM DRILL BIT/MQC/75MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16363008 ↗
• MalfunctionNov 14, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE SURGEON EXPERIENCED DIFFICULTY DRILLING WITH THE DRILL BITS IN QUESTION. CUTTING WAS NOT GOOD, AND THE DRILLING WAS DELAYED BECAUSE OF IT. THE BIT WAS CHANGED AND THE HOLES WERE ABLE TO BE DRILLED, BUT WITH GREAT DIFFICULTY. ADDITIONALLY, THE GUIDE WOULD NOT SCREW TO THE PLATES OF 1.5, IT COULD NOT BE USED. THIS REPORT IS FOR A 1.1MM DRILL BIT/MQC/75MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15787845 ↗
• MalfunctionNov 14, 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 SURGEON EXPERIENCED DIFFICULTY DRILLING WITH THE DRILL BITS IN QUESTION. CUTTING WAS NOT GOOD, AND THE DRILLING WAS DELAYED BECAUSE OF IT. THE BIT WAS CHANGED AND THE HOLES WERE ABLE TO BE DRILLED, BUT WITH GREAT DIFFICULTY. ADDITIONALLY, THE GUIDE WOULD NOT SCREW TO THE PLATES OF 1.5, IT COULD NOT BE USED. THIS REPORT IS FOR A 1.1MM DRILL BIT/MQC/75MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15787844 ↗