NA 316.385Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10886982257772), received between Apr 11, 2018 and May 6, 2026 — classified as 5 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Break” (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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Break; Entrapment of Device

  IT WAS REPORTED THAT A DRILL BIT Ø0.8 L40/16 2FLUTE BROKE DURING A PROCEDURE. WHILE DRILLING TO MAKE HOLES IN THE BONE, THE DRILL BIT FRACTURED UPON REMOVAL, LEAVING A SMALL FRAGMENT EMBEDDED IN THE PATIENT'S BONE. THE SURGEON WAS UNABLE TO EXTRACT THE FRAGMENT AND ELECTED TO LEAVE IT IN PLACE, AS IT WAS NOT LOCATED WITHIN A JOINT AND WAS NOT EXPECTED TO CAUSE HARM. THE REMAINING PORTION OF THE DRILL BIT WAS REMOVED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER DRILL BIT OF THE SAME SPECIFICATIONS. THERE WAS NO REPORTED IMPACT OR CONSEQUENCE TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 25095863 ↗
• MalfunctionApr 27, 2026Break

  IT WAS REPORTED THAT DURING THE DRILLING OPERATION USING THE GUIDE, THE 0.8 MM DRILL BIT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25008100 ↗
• MalfunctionDec 9, 2025Break; Break

  DURING A PROCEDURE, THE TIPS OF TWO (2) DRILL BITS BROKE WHILE DRILLING. THE FRAGMENTS WERE COMPLETELY REMOVED EACH TIME, AND REPLACEMENT DRILL BITS FROM THE KIT WERE USED TO CONTINUE THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY, THERE WERE NO ADVERSE EFFECTS ON THE PATIENT, AND THE SURGICAL SCHEDULE WAS NOT ALTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23757302 ↗
• MalfunctionSep 11, 2025Break; Break

  IT WAS REPORTED THAT THE DRILL BIT FRACTURED WHEN POSITIONING THE DRILL GUIDE; IT DID NOT FRACTURE WITHIN THE BONE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23026726 ↗
• MalfunctionJun 6, 2025Break; Break

  IT WAS REPORTED THAT THE DRILL BIT AFTER DRILLING IS BROKEN, REMAINS WEAK AND . IT DOES NOT AFFECT THE PATIENT AND RUPTURE OCCURS AFTER PERFORATION OUTSIDE THE PATIENT'S LIMB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22161561 ↗
• MalfunctionApr 29, 2025Break; Break

  IT WAS REPORTED THAT 2 DRILL BITS BROKE INTRAOPERATIVELY. NO FURTHER INFORMATION IS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21927638 ↗
• MalfunctionApr 29, 2025Break; Break

  IT WAS REPORTED THAT 2 DRILL BITS BROKE INTRAOPERATIVELY. NO FURTHER INFORMATION IS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21927635 ↗
• MalfunctionFeb 10, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE DRILL BECAME BENT AFTER DRILLING TO MAKE A COMPRESSION. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21344229 ↗
• MalfunctionFeb 4, 2025Break; Break

  DURING THE PROCEDURE, AT THE TIME OF PERFORMING THE OSTEOSYNTHESIS ON THE RIGHT HAND PHALANX AND WHEN STARTING THE FIRST PERFORATION WITH A # 0.8 DRILL BIT TO PLACE A 0.1 SCREW, THE DRILL BIT BROKE IN HALF AT THAT MOMENT. IT IS NOT KNOWN EXACTLY WHERE THE OTHER PART OF THE DRILL BIT FELL, WHICH IS WHY IT WAS VERIFIED WITH X-RAYS THAT IT HAD NOT REMAINED INSIDE THE PATIENT'S BONE. THE PROCEDURE CONTINUED WITH ANOTHER DRILL BIT WITH THE SAME CHARACTERISTICS THAT ALSO CAME WITH THE EQUIPMENT AND THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT COMPLICATIONS, WITHOUT DISCOMFORT FOR THE SPECIALIST, WITHOUT AFFECTATIONS TO THE PATIENT AND WITHOUT ALTERATIONS IN SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21305751 ↗
• MalfunctionJan 29, 2025Break; Break

  IT WAS REPORTED THAT DURING SURGERY, AT THE MOMENT OF PASSING THE SECOND CORTICAL, THE BIT WAS BROKEN. THERE WAS NO DELAY IN THE PROCEDURE SINCE THE TIP CAME OUT WITHOUT INCONVENIENCES.

  Patient problems: Insufficient Information

  MAUDE report 21265708 ↗
• MalfunctionJan 8, 2025Break; Break

  IT WAS REPORTED THAT ON DECEMBER 11, 2024, THE DRILL BIT 0.8 BROKE DURING SURGERY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21101170 ↗
• MalfunctionMar 8, 2024Break; Break

  THERE WAS NO SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME AND STATUS WAS REPORTED AS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18865325 ↗
• MalfunctionMar 8, 2024Break; Break

  THERE WAS NO SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME AND STATUS WAS REPORTED AS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18865323 ↗
• MalfunctionJun 22, 2023Break; Break

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A VISUAL EXAMINATION THE DEVICE WAS FOUND TO BE BROKEN. THIS REPORT INVOLVES ONE (1) 0.8MM DRILL BIT/MQC FOR THREADED HOLE/47MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17183226 ↗
• InjuryJun 5, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, THE DRILL BIT BROKE AND REMAINED INSIDE THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 0.8MM DRILL BIT/MQC FOR THREADED HOLE/47MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 17059611 ↗
• MalfunctionMay 19, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED ON UNKNOWN DATE THAT THE LOAN ORTHOKIT ARRIVED WITH TWO BROKEN DRILL BITS. PATIENT STATUS OR CONSEQUENCE IS UNKNOWN. THIS REPORT IS FOR ONE (1) DRILL BIT Ø0.8 L40/16 2FLUTE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16961045 ↗
• MalfunctionMay 18, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE 0.8 DRILL BIT WAS FRACTURED DURING THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 0.8MM DRILL BIT/MQC FOR THREADED HOLE/47MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16952111 ↗
• MalfunctionMay 15, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED, THAT DURING A PROCEDURE ON (B)(6) 2023, THE DOCTOR SPLIT THE 0.8 DRILL BIT AND GUIDE FOR THE 2.7 THREADED BIT IN TWO. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 0.8MM DRILL BIT/MQC FOR THREADED HOLE/47MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16930231 ↗
• MalfunctionMay 3, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT THE DRILL BIT BROKE DURING THE PROCEDURE ON (B)(6) 2023. THE EVENT DID NOT COMPROMISE PATIENT SAFETY. THE DRILL SEGMENT WAS REMOVED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT INVOLVES ONE 0.8MM DRILL BIT/MQC FOR THREADED HOLE/47MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16860073 ↗
• MalfunctionApr 13, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT DURING THE PROCEDURE ON (B)(6)2023, THE TWO (2) 0.8 DRILL BITS ARE SPLIT. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 0.8MM DRILL BIT/MQC FOR THREADED HOLE/47MM THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16737537 ↗
• MalfunctionApr 13, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT DURING THE PROCEDURE ON (B)(6) 2023, THE TWO (2) 0.8 DRILL BITS ARE SPLIT. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 0.8MM DRILL BIT/MQC FOR THREADED HOLE/47MM THIS IS REPORT 1 OF 2 FOR COMPLAINT(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16737535 ↗
• MalfunctionApr 11, 2023No Apparent Adverse Event; No Apparent Adverse Event

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT THE ITEM WAS RECEIVED AS A BLIND UNIT FROM COLOMBIA ON (B)(6), 2022. THERE WAS NO ALLEGATION REPORTED AGAINST THE DEVICE. IT WAS FOUND UPON PRODUCT INSPECTION ON (B)(6)2023 THAT THE ITEM WAS BROKEN FROM THE DISTAL TIP. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 0.8MM DRILL BIT/MQC FOR THREADED HOLE/47MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16715832 ↗
• InjuryMar 2, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, WHILE DRILLING, THE DRILL BIT BROKE AND IT REMAINED INSIDE THE PATIENT WHICH COULD NOT BE EXTRACTED. THIS REPORT IS FOR ONE (1) 0.8MM DRILL BIT/MQC FOR THREADED HOLE/47MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 16467395 ↗
• MalfunctionFeb 22, 2023Break; Break

  DEVICE REPORT FROM BELGIUM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A HAND TRAUMA SURGERY ON (B)(6) 2023, A DRILL BIT BROKE. THE BROKEN OF PART WAS RETRIEVED AND DISPOSED OF BY THE HOSPITAL. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR A 0.8MM DRILL BIT/MQC FOR THREADED HOLE/47MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16420863 ↗
• MalfunctionJan 6, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE 0.8 DRILL BIT SPLIT DURING THE PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY IN THE SURGERY. THIS REPORT INVOLVES ONE 0.8MM DRILL BIT/MQC FOR THREADED HOLE/47MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16114018 ↗