NA 03.130.212Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886982075369), received between Oct 3, 2019 and Mar 26, 2026 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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 24698278 ↗
• 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 24698272 ↗
• MalfunctionMar 18, 2026Failure to Cut

  DURING SURGERY, IT WAS NOTED THAT THE IDENTIFIED DRILL BITS LISTED IN THIS COMPLAINT 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. REPLACEMENTS ARE REQUIRED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24627523 ↗
• MalfunctionJan 26, 2026Break

  IT WAS REPORTED THAT DURING THE PROCEDURE A 1.5 MM DRILL BIT WAS FRACTURED DURING DRILLING. THE PROBLEM WAS IMMEDIATELY RESOLVED BY REMOVING THE BIT TOGETHER WITH THE FRAGMENT AND USING ANOTHER BIT WITH THE SAME CHARACTERISTICS. THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WERE NO IMPACT TO THE PATIENT OR ALTERATIONS IN THE SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24182966 ↗
• MalfunctionJul 15, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE AT THE TIME THE BONE DRILLING WAS CARRIED OUT THE BIT BROKE, RESOLVED BY REMOVING THE BIT AND PASSING ANOTHER OF THE SAME REFERENCE AND CHARACTERISTICS THAT ALSO COMES INSIDE THE EQUIPMENT. AFTER THIS IT WAS ALSO PRESENTED THAT WHEN PLACING THE SCREWS THE TIP OF THE SCREWDRIVER BROKE. THIS NOVELTY WAS RESOLVED BY REMOVING THIS SCREWDRIVER AND PASSING ANOTHER OF THE SAME CHARACTERISTICS THAT ALSO COMES WITHIN THE EQUIPMENT, THUS ACHIEVING SUCCESSFUL COMPLETION OF THE SURGERY; FOR THESE NOVELTIES THERE WERE NO DISCOMFORT ON THE PART OF THE SPECIALIST SINCE THERE WAS HOW TO GIVE A QUICK SOLUTION, THERE WERE NO AFFECTIONS TO THE PATIENT AND NEITHER ALTERATIONS IN THE SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22511841 ↗
• MalfunctionFeb 5, 2025Break; Break

  IT WAS REPORTED THAT WHEN THE DOCTOR IS DRILLING THE BONE, THE DRILL BROKE. IT DID NOT GET EMBEDDED IN THE BONE, SO IT WAS REMOVED WITHOUT INCIDENT, AND THE SURGERY WAS COMPLETED SATISFACTORILY WITHOUT ANY PROBLEMS.

  Patient problems: Insufficient Information

  MAUDE report 21314985 ↗
• MalfunctionApr 2, 2024Failure to Cut; Failure to Cut

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT DURING THE SURGERY ON (B)(6) 2024, IT WAS IDENTIFIED THAT THE DRILLS OF THE 1.5 SYSTEM WERE DAMAGED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 1.5MM DRILL BIT/MQC FOR GLIDING HOLE/48MM THIS IS REPORT 1 OF 6 FOR COMPLAINT (B)(4).

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

  MAUDE report 19020509 ↗
• MalfunctionFeb 21, 2024Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM FRANCE REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON JANUARY 17, 2024, THE DRILL BIT DIAMETER 1.5MM BROKE INSIDE THE PATIENT'S BONE. THE MOTOR USED FOR THE DRILLING WAS A COLIBRI MOTOR. A FRAGMENT WAS LEFT IN THE BONE. THE SURGEON CONSIDERED THE SEVERITY MINOR AND WILL MONITOR THE PATIENT TO ENSURE THAT SCREWS DO NOT MIGRATE. AN ATTEMPT WILL BE MADE TO REMOVE THE INSTALLED MATERIAL. THIS REPORT IS FOR A 1.5MM DRILL BIT/MQC FOR THREADED HOLE/74MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18751352 ↗
• MalfunctionDec 21, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN UNKNOWN SURGERY USING THE DRILL BIT. THE DRILL BIT BROKE DURING THE SURGERY AND REMAINED IN THE PATIENT¿S BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY, AND THE PATIENT STATUS WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE 1.5MM DRILL BIT/MQC FOR GLIDING HOLE/48MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18371424 ↗
• MalfunctionOct 25, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE DRILL BIT IN QUESTION BROKE DURING SURGERY. DURING THE PROCEDURE, THE DRILL BIT WAS PASSED TO THE OPEN CHANNEL THROUGH THE PLATE, BUT WAS FOUND TO HAVE FRACTURED AT THE TIP WHEN IT WAS REMOVED. THE FRAGMENT REMAINS INSIDE OF THE PATIENT BONE, THE FRAGMENT COULD NOT BE REMOVED DUE TO THE PHALANX BEING LOCKED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.5MM DRILL BIT/MQC FOR GLIDING HOLE/48MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18005362 ↗
• InjuryOct 22, 2020Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, THE DRILL BIT BROKE. THE TIP REMAINED INSIDE THE PATIENT. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 1.5MM DRILL BIT/MQC FOR GLIDING HOLE/48MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 10717773 ↗
• InjuryOct 3, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DRILL BIT (03.130.212) BROKE INTRAOPERATIVELY DURING NORMAL USE. UPON SNAPPING THE DISTAL FRAGMENT BECAME AIRBORNE, PIERCING THROUGH THE SURGEON¿S MASK AND INTO HIS CHIN BENEATH. THE PROCEDURE (ORIF OSTEOTOMY 5TH METACARPAL) SUCCESSFULLY COMPLETED WITH SPARE DRILL BIT ON SET. PATIENT CONDITION IS UNKNOWN. THIS IS REPORT 1 FOR 1 (B)(4).

  Patient problems: No Code Available

  MAUDE report 9151844 ↗