NA 310.431Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886982186638), received between Dec 14, 2017 and Jan 29, 2026 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (8 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2026Failure to Cut

  DURING THE SURGERY, IT WAS EVIDENT THAT THE TIPS OF THE DRILL BITS WERE DULL. THE SPECIALIST EXPRESSED DISSATISFACTION DUE TO THE DULLNESS OF THE DRILL BITS, WHICH PROLONGED THE SURGERY BY TEN MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24215376 ↗
• MalfunctionDec 5, 2025Failure to Cut; Material Deformation; Failure to Cut; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE, TWO DRILL BITS WERE DAMAGED WHILE DRILLING; ONE BROKE AND ANOTHER BENT, RENDERING BOTH UNUSABLE. NO FRAGMENTS REMAINED IN THE PATIENT. THE DAMAGED BITS WERE REPLACED WITH OTHERS OF THE SAME TYPE FROM THE KIT, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY IMPACT OR CONSEQUENCE TO THE PATIENT, NOR WAS THE SURGICAL TIMELINE AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23729075 ↗
• MalfunctionSep 20, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING LOAN KIT INSPECTION BY THE LOAN KIT TECHNICIAN IT WAS NOTED THAT THESE INSTRUMENTS ARE COMPOSED OF 1 PART, THE DRILL BIT GOT STUCK IN THE DRILL SLEEVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20268960 ↗
• MalfunctionJan 4, 2024Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT THEY HAVE NO EDGE, GENERATES DISAGREEMENT IN THE SPECIALIST. THIS REPORT IS FOR ONE (1)DRILL BIT Ø4.3 L180 F/QUICK COUP THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18442706 ↗
• MalfunctionSep 28, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE DRILL BITS IN QUESTION WERE FOUND TO BE DULL AND WOULD NOT CUT AS INTENDED. THE DRILL BITS DID NOT PASS THROUGH THE BONE, CAUSING OVERHEATING AND A DELAY IN REDUCTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 4.3MM DRILL BIT/QC/180MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17839613 ↗
• MalfunctionJul 11, 2023Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 16-JUNE-2023, WHEN MAKING PROXIMAL BLOCKS OF THE PLATE, THE DRILL BIT BROKE. THE FRAGMENTS GENERATED WERE ABLE TO BE REMOVED WITH A TWEEZER. THERE WERE NO REPORTED ADVERSE PATIENT OUTCOMES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 4.3MM DRILL BIT/QC/180MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17298631 ↗
• MalfunctionFeb 13, 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 DRILL BITS WERE DULL DURING AN ORTHOPEDIC PROCEDURE. THIS REPORT INVOLVES ONE 4.3MM DRILL BIT/QC/180MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16364570 ↗
• MalfunctionSep 26, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE DRILL BIT BROKE WHEN IT MADE CONTACT WITH THE BONE. IT DID NOT SCREW WELL. THIS REPORT INVOLVES ONE 4.3MM DRILL BIT/QC/180MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15484426 ↗
• MalfunctionJul 8, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED ON (B)(6)2022, DURING THE FEMUR FRACTURE FIXATION ,THE DRILLS COULD NOT ADEQUATELY CUT THE BONE, INCREASING THE TIME FOR SURGERY. SURGERY HAD GOOD OUTCOME. THERE IS NO FURTHER INFORMATION. THIS REPORT IS FOR ONE (1)DRILL BIT Ø4.3 L180 THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14955768 ↗
• MalfunctionSep 15, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE IN 2021, THE DRILL BIT WAS DULL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) 4.3MM DRILL BIT/QC/180MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12475809 ↗
• MalfunctionOct 1, 2020Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE DRILL BITS WERE BLUNT. PATIENT INVOLVEMENT WAS UNKNOWN. THIS REPORT INVOLVES ONE (1) 4.3MM DRILL BIT/QC/180MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

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

  MAUDE report 10612528 ↗
• InjuryOct 22, 2018Break; Break

  IT WAS REPORTED THAT DURING REVISION FOR OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE DISTAL FEMUR, THE DRILL BIT BROKE OFF AND THERE WAS PART OF THE DRILL BIT THAT WAS LEFT INTO THE PATIENT. THERE WAS ABOUT ONE MINUTE SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE USE OF PERCUTANEOUS DRILL BIT AS THE BACK-UP DEVICE. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Not Applicable

  MAUDE report 7991361 ↗
• InjuryFeb 7, 2018Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT, DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A DISTAL FEMUR ON (B)(6) 2018, A DRILL BIT BROKE AND WAS LEFT INSIDE THE PATIENT. SURGEON WAS FORCING THE DRILL BIT AND BROKE IT. THE BROKEN PART WAS LOST IN THE PATIENT. THE PATIENT HAS A KNEE REPLACEMENT, AND THAT PREVENTED THE X-RAY TO REVEAL WHERE THE BROKEN FRAGMENT WAS IN THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WEREN'T ANY NEGATIVE RESULTS. THIS REPORT IS FOR ONE (1) 4.3MM DRILL BIT/QC/180MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7248912 ↗
• MalfunctionDec 14, 2017Break; Break

  CONCOMITANT DEVICE REPORTED: TISSUE PROTECTOR (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY (B)(4)).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7118596 ↗