NA 324.212Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10886982191267), received between Nov 19, 2018 and Jan 13, 2026 — classified as 2 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (30 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 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN PERFORMING THE BROCADE TO INSERT A CORTICAL SCREW, THE CALIBRATED PERCUTANEOUS BIT (LENGTH 300/200 L52316 MM; QUICK ANCHOR) WAS FRACTURED. THE PROBLEM WAS IMMEDIATELY RESOLVED BY REMOVING THE DRILL BIT AND GIVING THE DOCTOR ANOTHER BIT OF THE SAME CHARACTERISTICS THAT ALSO CAME IN THE EQUIPMENT, WITH WHICH THE SURGERY WAS SUCCESSFULLY COMPLETED. DUE TO THIS NOVELTY, THERE WERE NO DISCOMFORT ON THE PART OF THE SPECIALIST, THERE WERE NO AFFECTIONS TO THE PATIENT OR ALTERATIONS IN THE SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24055681 ↗
• MalfunctionAug 18, 2025Break; Break

  DURING THE PROCEDURE, THE DRILL BIT BREAKS OFF AND NO FRAGMENT REMAINS IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22835371 ↗
• MalfunctionJun 24, 2025Break; Break

  IT WAS REPORTED THAT THE DRILL BIT HAS BROKEN WHILE THE SURGEON WAS DRILLING TO INSERT THE SCREW. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320627 ↗
• MalfunctionJun 24, 2025Break; Break

  IT WAS REPORTED THAT THE DRILL BIT HAS BROKEN WHILE THE SURGEON WAS DRILLING TO INSERT THE SCREW. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320582 ↗
• MalfunctionJun 24, 2025Break; Break

  IT WAS REPORTED THAT THE DRILL BIT HAS BROKEN WHILE THE SURGEON WAS DRILLING TO INSERT THE SCREW. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320561 ↗
• MalfunctionJun 24, 2025Break; Break

  IT WAS REPORTED THAT THE DRILL BIT HAS BROKEN WHILE THE SURGEON WAS DRILLING TO INSERT THE SCREW. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320559 ↗
• MalfunctionDec 12, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE EDGES OF 3.2MM DRILL WERE DAMAGED DURING THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 20918501 ↗
• MalfunctionNov 18, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE OUTCOME OF THE PROCEDURE WAS SATISFACTORY AND NO OTHER MEDICAL INTERVENTION NEEDED. THERE WAS NO INVOLVEMENT OF THE PATIENT, THERE WERE NO FRAGMENTS LEFT IN HIM.

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

  MAUDE report 20716510 ↗
• MalfunctionSep 18, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6) 2024, THE MATERIAL HAD NO EDGE. THERE WAS DISCOMFORT IN THE SPECIALIST. THE PROCEDURE WAS NOT DELAYED, AND THE SURGERY WAS SUCCESSFUL.

  Patient problems: Insufficient Information

  MAUDE report 20250833 ↗
• MalfunctionSep 18, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6) 2024 , THE MATERIAL HAD NO EDGE. THERE WAS DISCOMFORT IN THE SPECIALIST. THE PROCEDURE WAS NOT DELAYED, AND THE SURGERY WAS SUCCESSFUL.

  Patient problems: Insufficient Information

  MAUDE report 20249421 ↗
• MalfunctionApr 26, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6) 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) 3.2MM PERCUTANEOUS DRILL BIT QC/300MM/CALIBRATED THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19193514 ↗
• MalfunctionOct 24, 2023Break; Material Deformation; Break; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, WHEN THE SURGEON WAS DRILLING, THE TIP OF THE DRILL BIT BROKE, AND THE DISTAL EDGES WERE DEFORMED BY THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE 3.2MM PERCUTANEOUS DRILL BIT QC/300MM/CALIBRATED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17994989 ↗
• 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 3.2MM 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 17839609 ↗
• 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) 3.2MM PERCUTANEOUS DRILL BIT QC/300MM/CALIBRATED. . THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Burn(s)

  MAUDE report 17782425 ↗
• 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) 3.2MM PERCUTANEOUS DRILL BIT QC/300MM/CALIBRATED. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Burn(s)

  MAUDE report 17782239 ↗
• MalfunctionJul 19, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6) 2023, THE DRILL BIT IN QUESTION WAS FOUND TO BE DULL WHEN IT WAS REMOVED FROM ITS PACKAGING. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 3.2MM PERCUTANEOUS DRILL BIT QC/300MM/CALIBRATED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17349531 ↗
• MalfunctionJun 20, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT THE DEVICE WAS RECEIVED AS A BLIND UNIT. UPON PRODUCT EXAMINATION ON JUNE 1, 2023, IT WAS NOTED THAT THE DEVICE WAS STRIPPED FROM THE DRILLING SHAFT. NO FURTHER INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17162997 ↗
• 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 16336095 ↗
• 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 16336021 ↗
• 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) 3.2MM PERCUTANEOUS DRILL BIT QC/300MM/CALIBRATED. THIS IS REPORT 2 OF 2 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15714354 ↗
• MalfunctionOct 11, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) 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 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15579784 ↗
• MalfunctionOct 11, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) 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 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15579714 ↗
• MalfunctionOct 10, 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 ARE DULL. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) 3.2MM PERCUTANEOUS DRILL BIT QC/300MM/CALIBRATED. THIS IS REPORT 1 OF 1 FOR PC:(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15574020 ↗
• 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. THIS REPORT IS FOR ONE (1)DRILL BIT Ø3.2 PERCUT CALIBR L300/200 F/. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15537710 ↗
• 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 3.2MM PERCUTANEOUS DRILL BIT QC/300MM/CALIBRATED. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15519000 ↗