NA 310.16Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982186041), received between May 29, 2018 and Oct 8, 2024 — 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.

• MalfunctionOct 8, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING THE SURGERY THE DRILL BIT BROKE. THERE WERE NO FRAGMENTS LEFT IN THE PATIENT. THE DRILL BIT WAS REPLACED AND CONTINUED WITH SURGERY. NO COMPLICATIONS. SURGERY SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20397740 ↗
• MalfunctionSep 25, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2024 AFTER A CASE, THE SURGEON WAS USING THE DRILL GUIDE AND COMPLAINED THAT BOTH 1.5MM DRILL BITS WOBBLING IN THE POWER DRILL. THE DRILL BITS WAS RETRIEVED FROM THE SCRUB AFTER THE CASE WAS COMPLETED AND NOTICED THAT THERE APPEARS TO BE A SLIGHT BEND IN BOTH DRILL BITS TOWARD THE QUICK CONNECT. THERE WAS NO GENERATION OF FRAGMENTS. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20305848 ↗
• MalfunctionSep 25, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  ADDITIONAL INFORMATION RECEIVED STATES THAT NO OTHER MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20305843 ↗
• MalfunctionAug 30, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT ALL OF THE DRILL BITS ARE DULL. IT WAS UNKNOWN IF THERE WAS ANY PROCEDURE INVOLVED. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES 30 DEVICES. THIS REPORT IS FOR (1)1.5MM DRILL BIT/QC/110MM. THIS REPORT IS 14 OF 20 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12389126 ↗
• MalfunctionAug 30, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT ALL OF THE DRILL BITS ARE DULL. IT WAS UNKNOWN IF THERE WAS ANY PROCEDURE INVOLVED. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES 30 DEVICES. THIS REPORT IS FOR (1)1.5MM DRILL BIT/QC/110MM. THIS REPORT IS 12 OF 20 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12389109 ↗
• MalfunctionAug 30, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT ALL OF THE DRILL BITS ARE DULL. IT WAS UNKNOWN IF THERE WAS ANY PROCEDURE INVOLVED. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES 30 DEVICES. THIS REPORT IS FOR (1) 1.5MM DRILL BIT/QC/110MM. THIS REPORT IS 13 OF 20 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12389106 ↗
• MalfunctionAug 30, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT ALL OF THE DRILL BITS ARE DULL. IT WAS UNKNOWN IF THERE WAS ANY PROCEDURE INVOLVED. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES 30 DEVICES. THIS REPORT IS FOR (1)1.5MM DRILL BIT/QC/110MM. THIS REPORT IS 10 OF 20 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12388811 ↗
• MalfunctionAug 30, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT ALL OF THE DRILL BITS ARE DULL. IT WAS UNKNOWN IF THERE WAS ANY PROCEDURE INVOLVED. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES 30 DEVICES. THIS REPORT IS FOR (1) 1.5MM DRILL BIT/QC/110MM. THIS REPORT IS 6 OF 20 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12388760 ↗
• MalfunctionMay 29, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT AN ELBOW SURGERY. DURING THE PROCEDURE, THE TWO (2) DRILL BITS BROKE WHILE THE SURGEON WAS DRILLING. THE FRAGMENTS WERE RETRIEVED AND NOT RETAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITH NO REPORTED DELAY. PATIENT STATUS IS GOOD. THIS REPORT IS FOR A 1.5MM DRILL BIT/QC/110MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7550174 ↗