"1.5MM" SYSTEM 01-7144Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00841036013165), received between Apr 26, 2019 and Jul 7, 2025 — classified as 11 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Fracture” (29 reports).

1 other recall cover devices cleared under the same FDA submission (K062842); they may or may not involve this specific model.

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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2025Fracture; Fracture

  IT IS REPORTED THAT WHILE THE SURGEON WAS USING THE DRILL BIT TO DRILL THROUGH THE MUCOSA AND BONE TO PLACE 1.5MM SCREWS FOR IMF FIXATION, THE DRILL BIT FRACTURED. THIS ALSO HAPPENED WITH ANOTHER DRILL BIT. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412840 ↗
• MalfunctionJun 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INITIAL PROCEDURE, A DRILL TIP FRACTURED. THE BROKEN TIP WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING BACKUP INSTRUMENTATION. THE SURGICAL TECHNIQUE WAS FOLLOWED. NO ADDITIONAL HARM TO THE PATIENT WAS REPORTED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22167410 ↗
• MalfunctionNov 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE DRILL WAS BROKEN DURING A PROCEDURE. ALL DEBRIS/FRAGMENTS WERE RECOVERED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20612258 ↗
• InjuryAug 22, 2024Fracture; Fracture

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20028481 ↗
• MalfunctionAug 6, 2024Fracture; Fracture

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19925341 ↗
• MalfunctionAug 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE DRILL FRACTURED DURING USE. DURING THE SURGERY, THE NURSE REPORTED TO THE SURGEON THAT THE DRILL WAS FRACTURED. THE SURGEON REMOVED ALL OF THE PLATES AND RETRIEVED THE DRILL TIP. PATIENT WAS RE-FIXED WITH A NEW PLATE AND SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19925185 ↗
• MalfunctionAug 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE DRILL FRACTURED DURING USE. THERE WERE NO CONSEQUENCES OR IMPACTS TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19919941 ↗
• MalfunctionApr 29, 2024Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19202966 ↗
• MalfunctionJul 17, 2023Fracture; Fracture

  IT IS REPORTED THAT DURING A PROCEDURE, THE TIP OF THE DRILL FRACTURED OFF. THE FRAGMENT WAS RECOVERED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING OTHER DRILLS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17332724 ↗
• InjuryJun 19, 2023Fracture; Fracture

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17153612 ↗
• InjuryJun 13, 2023Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17121267 ↗
• MalfunctionNov 22, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE THE TWIST DRILL FRACTURED. THE BROKEN DRILL TIP DID NOT REMAIN IN THE PATIENT'S BODY AND WAS RECOVERED. A DIFFERENT DRILL WAS USED TO COMPLETE THE PROCEDURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15842947 ↗
• MalfunctionJul 12, 2022Break

  IT WAS REPORTED THAT THE SURGEON CHECKED THE TIP WHILE USING THE DRILL TO MAKE A PILOT HOLE AND FOUND IT TO BE BROKEN. HE CONFIRMED THE SURGICAL FIELD AND RECOVERED THE BROKEN DRILL TIP, BUT IT WAS LOST IN THE CLEANING PROCESS. THE SURGERY WAS COMPLETED USING ANOTHER DRILL. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14991274 ↗
• MalfunctionJun 28, 2022Fracture

  IT WAS REPORTED THAT THE DRILL TIP FRACTURED DURING A ZYGOMATIC FRACTURE OPEN REDUCTION AND FIXATION. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14843142 ↗
• MalfunctionJun 16, 2022Fracture

  IT WAS REPORTED THAT THE MORNING AFTER AN OPEN REDUCTION AND FIXATION PROCEDURE, THE DRILL WAS NOTED TO HAVE FRACTURED. HOWEVER, THE SURGEON DID NOT NOTICE THE FRACTURED DURING THE SURGERY. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14712860 ↗
• InjuryMay 9, 2022Break; Difficult to Remove

  DRILL TIP BROKE AND WAS LEFT IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 14336736 ↗
• MalfunctionApr 26, 2022Fracture; Fracture

  IT WAS REPORTED A MALE SURGEON BROKE THE TIP OF A DRILL WHILE DRILLING A PILOT HOLE DURING AN OPEN REDUCTION AND FIXATION OF THE MAXILLA. HE RECOVERED THE BROKEN TIP AND CONTINUED THE OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14207838 ↗
• InjuryFeb 7, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A ZYGOMATIC FRACTURE OPEN BLOOD RESTORATION PROCEDURE, THE DRILL FRACTURED WHEN THE SURGEON ATTEMPTED TO MAKE THE FIRST HOLE IN THE PATIENT'S BONE. THE TIP OF THE DRILL REMAINS IN THE MAXILLARY SINUS. THERE IS NO SURGERY PLANNED TO REMOVE THE TIP. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13472449 ↗
• MalfunctionSep 7, 2021Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12435252 ↗
• InjuryNov 30, 2020Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10917837 ↗
• InjuryOct 30, 2020Fracture; Fracture

  IT WAS REPORTED THE DRILL TIP FRACTURED DURING A PROCEDURE. THE MAXILLARY ANTERIOR WALL WAS SECURED WITH A 1.5L PLATE AND THE DRILL BROKE DURING USE. THE NURSE NOTED THE FRACTURED PIECE COULD NOT BE LOCATED IN THE BODY AND THE DOCTOR TOOK AN X-RAY WHICH DID NOT SHOW THE FRACTURED PIECE. LATER THE FRACTURED PIECE OF THE DRILL WAS LOCATED IN THE SUCTION EFFLUENT BOTTLE AND THE PROCEDURE WAS RESUMED. THE SURGERY WAS COMPLETED WITH AN ALTERNATE DRILL. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10762730 ↗
• MalfunctionOct 1, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THE DRILL WAS DISCOVERED TO BE DAMAGED DURING A PROCEDURE ON THE INFRAORBITAL MARGIN. THE DRILL WAS INSPECTED PRIOR TO THE SURGERY, AND FOUND TO BE UNDAMAGED. PRIOR TO USE IN THE SURGERY, IT WAS FOUND TO BE DAMAGED, AND WAS NOT USED. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DRILL BIT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 10612917 ↗
• MalfunctionSep 15, 2020Fracture; Fracture

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10538758 ↗
• MalfunctionJul 9, 2020Fracture; Fracture

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10253373 ↗
• MalfunctionMar 16, 2020Fracture; Fracture

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9836490 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K062842. One submission often covers many models, so check the product and lot details in each record.

• Z-0538-2010 · Nov 6, 2009 · Terminated
  Biomet 1.1 X 50MM, 3.5MM STOP STAINLESS STEEL, 1.5MM SYSTEM TWIST DRILL WITH J NOTCH, REF 01-7141. DISTRIBUTED BY: BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218