NA 324.213Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10886982191274), received between Aug 31, 2020 and Mar 24, 2026 — classified as 2 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (31 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 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026Failure to Cut

  DURING THE PROCEDURE, WHILE DRILLING WITH DRILL BITS REFERENCES 324.213 (2 UNITS) // 310.630 (1 UNIT), IT WAS OBSERVED THAT THE INSTRUMENTS WERE NOT SHARP ENOUGH TO PERFORM THEIR FUNCTION, WHICH HINDERED DRILLING FOR THE SCREWS. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT AFFECTING THE PATIENT OR ALTERING THE SURGICAL SCHEDULE. ALSO, DURING THE PROCEDURE, UPON OPENING THE EQUIPMENT, IT WAS FOUND THAT ONE (1) UNIT OF SCREW REF 02.227.075 WAS MISSING FROM THE ANKLE SCREWS. THE REMITTANCE LISTED TWO (2) UNITS, BUT ONLY ONE (1) UNIT WAS PHYSICALLY PRESENT. THIS DID NOT AFFECT THE NORMAL COURSE OF THE SURGERY, AS THIS PARTICULAR SCREW WAS NOT NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24679388 ↗
• MalfunctionMar 24, 2026Failure to Cut

  DURING THE PROCEDURE, WHILE DRILLING WITH DRILL BITS REFERENCES (B)(4) (2 UNITS) // (B)(4) (1 UNIT), IT WAS OBSERVED THAT THE INSTRUMENTS WERE NOT SHARP ENOUGH TO PERFORM THEIR FUNCTION, WHICH HINDERED DRILLING FOR THE SCREWS. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT AFFECTING THE PATIENT OR ALTERING THE SURGICAL SCHEDULE. ALSO, DURING THE PROCEDURE, UPON OPENING THE EQUIPMENT, IT WAS FOUND THAT ONE (1) UNIT OF SCREW REF (B)(4) WAS MISSING FROM THE ANKLE SCREWS. THE REMITTANCE LISTED TWO (2) UNITS, BUT ONLY ONE (1) UNIT WAS PHYSICALLY PRESENT. THIS DID NOT AFFECT THE NORMAL COURSE OF THE SURGERY, AS THIS PARTICULAR SCREW WAS NOT NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24672894 ↗
• MalfunctionOct 23, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING SURGERY, WHEN TRYING TO PASS THE LONG 4.3 BIT, IT DID NOT EASILY PIERCE THE PATIENT'S BONE. IT WAS NECESSARY TO APPLY A LOT OF FORCE AND, EVEN SO, IT DID NOT SUCCEED. THIS CAUSED ADDITIONAL SURGICAL TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369695 ↗
• MalfunctionOct 23, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING SURGERY, WHEN TRYING TO PASS THE LONG 4.3 BIT, IT DID NOT EASILY PIERCE THE PATIENT'S BONE. IT WAS NECESSARY TO APPLY A LOT OF FORCE AND, EVEN SO, IT DID NOT SUCCEED. THIS CAUSED ADDITIONAL SURGICAL TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369685 ↗
• MalfunctionNov 18, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING THE USE OF THE 4.3 BIT, IT WAS BROKEN INSIDE THE BONE. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20707982 ↗
• MalfunctionApr 26, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON APRIL 22, 2024 DURING THE SURGERY THE DRILLS ON THE LOAN SET WERE VERY DULL. THERE WAS NO PATIENT HARM AND NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) 4.3MM PERCUTANEOUS DRILL BIT QC/300MM/CALIBRATED THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19193515 ↗
• MalfunctionApr 26, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON APRIL 22, 2024 DURING THE SURGERY THE DRILLS ON THE LOAN SET WERE VERY DULL. THERE WAS NO PATIENT HARM AND NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) 4.3MM PERCUTANEOUS DRILL BIT QC/300MM/CALIBRATED THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19193508 ↗
• MalfunctionMar 20, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRILL BIT BROKE. THIS REPORT INVOLVES ONE (1) DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18940023 ↗
• MalfunctionMar 6, 2024No Apparent Adverse Event; No Apparent Adverse Event

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 12-SEPTEMBER-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. UPON EXAMINATION OF RETURNED PRODUCTS ON FEBRUARY 21, 2024, IT WAS NOTED THAT AN ADDITIONAL DRILL BIT WAS DULL. THIS REPORT IS FOR A 4.3MM PERCUTANEOUS DRILL BIT QC/300MM/CALIBRATED. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18848703 ↗
• MalfunctionFeb 6, 2024Failure to Cut; Failure to Cut

  THE EVENT OCCURRED INTRAOPERATIVELY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18650681 ↗
• MalfunctionNov 13, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN BELGIUM AS FOLLOWS: IT WAS REPORTED THAT THE BIT WAS WORN AND DIDN'T CUT WELL. NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) 4.3MM PERCUTANEOUS DRILL BIT QC/300MM/CALIBRATED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18120737 ↗
• MalfunctionNov 13, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN BELGIUM AS FOLLOWS: IT WAS REPORTED THAT THE BIT WAS WORN AND DIDN'T CUT WELL. NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) 4.3MM PERCUTANEOUS DRILL BIT QC/300MM/CALIBRATED THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18120705 ↗
• 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 PERCUTANEOUS DRILL BIT QC/300MM/CALIBRATED. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17839614 ↗
• MalfunctionSep 20, 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, TWO DRILL BITS OF 3.2 AND 4.3 WERE BLUNT. IT TOOK A LONG TIME TO DRILL THE BONE, CAUSING BURN AND ADDITIONAL SURGICAL TIME. THIS REPORT INVOLVES ONE (1) 4.3MM PERCUTANEOUS DRILL BIT QC/300MM/CALIBRATED. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Burn(s)

  MAUDE report 17782843 ↗
• MalfunctionSep 20, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, TWO DRILL BITS OF 3.2 AND 4.3 WERE BLUNT. IT TOOK A LONG TIME TO DRILL THE BONE, CAUSING BURN AND ADDITIONAL SURGICAL TIME. THIS REPORT INVOLVES ONE (1) 4.3MM PERCUTANEOUS DRILL BIT QC/300MM/CALIBRATED. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Burn(s)

  MAUDE report 17782282 ↗
• MalfunctionMar 20, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT LOAN SET FROM BOOKING: 0111129412 HAD BEEN RECEIVED WITH INSTRUMENTS DIRTY FROM THE WAREHOUSE. THIS WAS DISCOVERED UPON INSPECTION AND PATIENT CARE WAS NOT AFFECTED. PATIENT STATUS/ OUTCOME / CONSEQUENCES ?NO THIS REPORT IS FOR ONE (1) DRILL BIT Ø4.3 PERCUT CALIBR L300/200 F/ THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16573878 ↗
• MalfunctionFeb 9, 2023Failure to Cut; Failure to Cut

  THE TIMING OF THE REPORTED EVENT WAS INTRA-OPERATIVE. THERE WAS NO PATIENT INVOLVEMENT WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16336131 ↗
• MalfunctionFeb 9, 2023Failure to Cut; Failure to Cut

  THE TIMING OF THE REPORTED EVENT WAS INTRA-OPERATIVE. THERE WAS NO PATIENT INVOLVEMENT WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16336110 ↗
• MalfunctionNov 2, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 3.2 AND 4.3 DRILL BITS NEED TO BE REPLACED AS THEY DO NOT CUT ENOUGH TO PENETRATE THE BONE. THERE IS A NEED TO BE PERFORATING UNTIL YOU CAN PENETRATE THE CORTISAL. THIS REPORT INVOLVES ONE (1) 4.3MM PERCUTANEOUS DRILL BIT QC/300MM/CALIBRATED. THIS IS REPORT 1 OF 2 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15714312 ↗
• MalfunctionOct 11, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE DRILL BITS WERE DULL. THIS REPORT INVOLVES ONE (1) DRILL BIT. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15579857 ↗
• MalfunctionOct 11, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE DRILL BITS WERE DULL. THIS REPORT INVOLVES ONE (1) DRILL BIT. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15579824 ↗
• MalfunctionOct 4, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT THE DRILL BIT ARE DULL. IT HAS NO INVOLVEMENT IN THE PATIENT.SPA THIS REPORT IS FOR ONE (1) DRILL BIT Ø4.3 PERCUT CALIBR L300/200 F/ THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15537696 ↗
• MalfunctionSep 30, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE DRILL BITS WERE DULL DURING SURGERY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 4.3MM PERCUTANEOUS DRILL BIT QC/300MM/CALIBRATED. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15519100 ↗
• MalfunctionSep 30, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE DRILL BITS WERE DULL DURING SURGERY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 4.3MM PERCUTANEOUS DRILL BIT QC/300MM/CALIBRATED. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15519098 ↗
• MalfunctionAug 11, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, ONE DRILL BIT BROKE INSIDE OF THE BONE, AND IT WAS NOT POSSIBLE TO EXTRACT THE FRAGMENT. THREE OTHER DRILL BITS WERE FOUND TO BE DULL DURING THE SAME PROCEDURE. THERE WAS A TOTAL SURGICAL DELAY OF APPROXIMATELY 30 MINUTES. SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR A 4.3MM PERCUTANEOUS DRILL BIT QC/300MM/CALIBRATED. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15208933 ↗