NA 03.130.102Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 10886982075239), received between Apr 7, 2017 and May 20, 2026 — classified as 11 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Break” (55 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 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026Break

  IT WAS REPORTED THE 1.0 DRILL BIT BROKE DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25232921 ↗
• MalfunctionMay 20, 2026Break

  IT WAS REPORTED THE DRILL BIT BROKE DURING A PROCEDURE. THE SPECIALIST INDICATED THAT THEY HURT THEMSELVES ON THE BROKEN DRILL BIT, BUT NO ADDITIONAL DETAILS ABOUT HOW THEY WERE HURT WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 25230891 ↗
• MalfunctionMar 26, 2026Failure to Cut

  DURING SURGERY, THE SURGEON COMPLAINED THAT THE DRILL BITS WERE DULL AND WERE NO LONGER FUNCTIONING TO THEIR OPTIMAL DRILLING CAPACITY. THESE COMPONENTS WERE DEEMED TO BE NO LONGER FUNCTIONAL, AND WERE SUBSEQUENTLY DISCARDED. IN ADDITION, MEDICAL DEVICE REPROCESSING STAFF IDENTIFIED THAT THE TIPS OF THE SCREWDRIVER SHAFTS WERE BENT AND SLIGHTLY DEFORMED. THESE ITEMS WERE DEEMED TO BE NO LONGER FUNCTIONAL AND WERE SUBSEQUENTLY DISCARDED. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698273 ↗
• MalfunctionMar 26, 2026Failure to Cut

  DURING SURGERY, THE SURGEON COMPLAINED THAT THE DRILL BITS WERE DULL AND WERE NO LONGER FUNCTIONING TO THEIR OPTIMAL DRILLING CAPACITY. THESE COMPONENTS WERE DEEMED TO BE NO LONGER FUNCTIONAL, AND WERE SUBSEQUENTLY DISCARDED. IN ADDITION, MEDICAL DEVICE REPROCESSING STAFF IDENTIFIED THAT THE TIPS OF THE SCREWDRIVER SHAFTS WERE BENT AND SLIGHTLY DEFORMED. THESE ITEMS WERE DEEMED TO BE NO LONGER FUNCTIONAL AND WERE SUBSEQUENTLY DISCARDED. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698270 ↗
• MalfunctionJan 12, 2026Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHILE PERFORMING THE DRILLING, BOTH DRILL BITS BROKE, AND BOTH DRILL BITS BENT. DESPITE THIS, THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY ADVERSE EFFECTS ON THE PATIENT OR CHANGES TO THE SURGICAL SCHEDULE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24037442 ↗
• MalfunctionJan 12, 2026Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHILE PERFORMING THE DRILLING, BOTH DRILL BITS BROKE, AND BOTH DRILL BITS BENT. DESPITE THIS, THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY ADVERSE EFFECTS ON THE PATIENT OR CHANGES TO THE SURGICAL SCHEDULE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24037204 ↗
• MalfunctionJan 12, 2026Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN PERFORMING THE BROCADE WITH THE Ø 1.0 MM BIT, THE BIT SPLIT. THE PROBLEM WAS IMMEDIATELY RESOLVED BY REMOVING THE BIT AND GIVING THE DOCTOR ANOTHER BIT OF THE SAME CHARACTERISTICS, INCLUDED IN THE EQUIPMENT, WITH WHICH THE SURGERY COULD BE 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 24036878 ↗
• MalfunctionNov 24, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHILE PERFORMING THE DRILLING WITH THE 1.0 MM DRILL BIT, THE TIP BROKE OFF, LEAVING A SMALL FRAGMENT INSIDE THE PATIENT'S BONE. SINCE IT COULD NOT BE REMOVED, THE DOCTOR DECIDED TO LEAVE THE FRAGMENT IN PLACE DUE TO THE DIFFICULTY OF EXTRACTION AND BECAUSE THERE WOULD BE NO PROBLEM LEAVING IT IN THE BONE. THE REMAINING PORTION OF THE AFOREMENTIONED DRILL BIT WAS THEN REMOVED, AND ANOTHER DRILL BIT OF THE SAME SPECIFICATIONS, ALSO AVAILABLE IN THE KIT, WAS USED. DESPITE THIS, THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY DELAYS.

  Patient problems: Foreign Body In Patient

  MAUDE report 23632443 ↗
• MalfunctionSep 5, 2025Break; Break

  DURING THE PROCEDURE AT THE TIME OF MAKING THE BROCADES, (2) TWO DRILL BITS BROKE. DRILL BIT FRAGMENTS WERE REMOVED. NEW DRILL BITS OF THE SAME TYPE WERE USED TO COMPLETE THE SURGERY SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22976214 ↗
• MalfunctionJul 8, 2025Break; Break

  IT WAS REPORTED THAT THE DOCTOR BROKE TWO DRILL BITS DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22440101 ↗
• MalfunctionJul 8, 2025Break; Break

  IT WAS REPORTED THAT THE DOCTOR BROKE TWO DRILL BITS DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22440100 ↗
• MalfunctionJun 18, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING THE PROCEDURE AT THE TIME OF DRILLING THE DRILL BIT BROKE. ANOTHER DRILL BIT OF THE SAME DIAMETER AND OF THE SAME CHARACTERISTICS WAS USED TO FINISH THE SURGERY SUCCESSFULLY. THERE WAS NO PATIENT HARM AND NO SURGICAL DELAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22287428 ↗
• MalfunctionJun 18, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED DURING THE LAST PERFORATION, THE 1.0 BIT WAS FRACTURED; A FRAGMENT WAS LEFT INSIDE THE PATIENT¿S BONE. IT DOES NOT CAUSE DISCOMFORT IN THE SPECIALIST OR AFFECT THE SURGICAL TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 22284364 ↗
• MalfunctionJun 2, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE 1.0 DRILL BIT BROKE, LEAVING A FRAGMENT OF IT INSIDE THE PATIENT'S BONE BECAUSE IT COULD NOT BE REMOVED. THE DOCTOR DECIDED TO LEAVE THIS FRAGMENT BEHIND BECAUSE IT WAS DIFFICULT TO EXTRACT. THIS PROBLEM WAS SOLVED BY INSERTING ANOTHER DRILL BIT OF THE SAME DIAMETER AND CHARACTERISTICS, ALSO INCLUDED WITH THE EQUIPMENT, THUS SUCCESSFULLY COMPLETING THE SURGERY WITHOUT DISCOMFORT FOR THE SPECIALIST AND WITHOUT ALTERATIONS IN SURGICAL TIMES. DURING AND AFTER THE SURGERY, THE PATIENT'S CONDITION WAS STABLE WITHOUT ANY ADDITIONAL COMPLICATIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 22123362 ↗
• MalfunctionMay 20, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE FLOAT BULLET DOES NOT FIT IN THE TRIALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22053557 ↗
• MalfunctionMay 20, 2025Break; Break

  IT WAS REPORTED THAT A DRILL BIT WAS BROKEN INTRAOPERATIVELY. IT WAS NOT IDENTIFIED THAT IT HAS BEEN INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22053413 ↗
• MalfunctionApr 2, 2025Break; Break

  IT WAS REPORTED THREE 0.8 DRILL BITS AND ONE 1.0 DRILL BIT FROM THE 1.3 COMPACT HAND SYSTEM WERE BROKEN DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21753487 ↗
• MalfunctionMar 19, 2025Break; Break

  IT WAS REPORTED THAT THERE WERE TWO (2) BROKEN DRILL BITS.

  Patient problems: Insufficient Information

  MAUDE report 21641675 ↗
• MalfunctionOct 29, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS A BROKEN DRILL BIT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20558891 ↗
• MalfunctionSep 4, 2024Break; Break

  IT WAS REPORTED THAT ON AUG 8, 2024 THE DEVICE BROKE. THERE WAS NO PATIENT INVOLVEMENT OR NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 1.0 DRILL BIT/MQC FOR THREADED HOLE/61 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20136746 ↗
• MalfunctionAug 21, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING THE PROCEDURE TWO BITS BROKE. THIS REPORT INVOLVES ONE (1) 1.0MM DRILL BIT/MQC FOR THREADED HOLE/61MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20015989 ↗
• MalfunctionDec 14, 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 DID NOT DRILL OR MOVE IN THE ENGINE WITHOUT ALLOWING THE BROCADE. THERE WAS NO DELAY IN THE SURGERY DUE TO THE USE OF OTHER SMOOTH DRILL BITS. THE SURGERY WAS ACHIEVED SUCCESSFULLY WITHOUT PATIENT CONSEQUENCE AND WITHOUT DELAY. THIS REPORT INVOLVES ONE 1.0MM DRILL BIT/MQC FOR THREADED HOLE/61MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18329095 ↗
• MalfunctionDec 14, 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 DID NOT DRILL OR MOVE IN THE ENGINE WITHOUT ALLOWING THE BROCADE. THERE WAS NO DELAY IN THE SURGERY DUE TO THE USE OF OTHER SMOOTH DRILL BITS. THE SURGERY WAS ACHIEVED SUCCESSFULLY WITHOUT PATIENT CONSEQUENCE AND WITHOUT DELAY. THIS REPORT INVOLVES ONE 1.0MM DRILL BIT/MQC FOR THREADED HOLE/61MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18329089 ↗
• MalfunctionDec 11, 2023Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, WHEN THE MOTOR OF THE DRILL WAS ACTIVATED, THE DRILL BIT GOT TANGLED WITH THE GLOVE OF THE SURGICAL TECH AND BROKE. THERE WAS NO PATIENT INVOLVEMENT, AND NO INJURY OR DISCOMFORT TO THE SURGICAL TEAM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A DRILL BIT FROM ANOTHER SET WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.0MM DRILL BIT/MQC FOR THREADED HOLE/61MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18305409 ↗
• MalfunctionNov 30, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLUMBIA AS FOLLOWS: IT WAS REPORTED THE DRILL BIT BROKE INTRAOPERATIVELY DURING THE PROCEDURE ON (B)(6), 2023 THIS REPORT IS FOR DRILL BIT Ø1 L61/31 F/CORE HOLE FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18238389 ↗