2.0MM SYSTEM 01-9196Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00841036016968), received between Jan 17, 2020 and Apr 1, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Fracture” (11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2025Fracture; Fracture

  IT WAS REPORTED THAT A DRILL FRACTURED NEAR THE ROOT DURING AN INITIAL FIXATION PROCEDURE. THE CORRECT SURGICAL TECHNIQUE WAS USED AND THE SURGEON NOTED THAT THE BREAKAGE MAY HAVE OCCURRED DUE TO THE APPLICATION OF OBLIQUE FORCE ON A LONG DRILL WITHOUT A GUIDE. THE FRACTURED DRILL TIP WAS SUCCESSFULLY REMOVED, AND THE CASE WAS COMPLETED WITHOUT ANY ADVERSE OUTCOMES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21742672 ↗
• MalfunctionMar 28, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE DRILL TIP FRACTURED WHILE IN USE DURING A PROCEDURE. THE DRILL TIP REMAINED IN THE PATIENT SO THE SURGEON PROCEEDED TO REMOVE THE FRAGMENT. THE SURGEON INJURED HIS FINGER WHILE REMOVING THE DRILL FRAGMENT. THERE WAS NO FURTHER INFORMATION PROVIDED FOR THE SURGEON'S INJURY. NO FRAGMENTS WERE RETAINED BY THE PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

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

  MAUDE report 19001294 ↗
• MalfunctionFeb 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE DRILLS FRACTURED WHILE DRILLING A HOLE FOR SCREW INSERTIONS DURING AN OSTEOTOMY PROCEDURE FOR JAW DEFORMITY. ANOTHER DRILL WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18627508 ↗
• MalfunctionFeb 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE DRILLS FRACTURED WHILE DRILLING A HOLE FOR SCREW INSERTIONS DURING AN OSTEOTOMY PROCEDURE FOR JAW DEFORMITY. ANOTHER DRILL WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18627499 ↗
• MalfunctionDec 18, 2023Fracture; Fracture

  IT IS REPORTED THAT DURING AN OSTEOTOMY PROCEDURE, THE DRILL TIP FRACTURED WHILE DRILLING TO INSERT A SCREW. NO FRAGMENTS WERE RETAINED BY THE PATIENT, AND THERE WAS NO HARM OR INJURY REPORTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DRILL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18345479 ↗
• MalfunctionNov 7, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE DRILL FRACTURED DURING AN INTERMAXILLARY FIXATION PROCEDURE. ANOTHER DRILL WAS USED TO COMPLETE THE PROCEDURE.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 18084769 ↗
• MalfunctionNov 7, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18084745 ↗
• MalfunctionAug 9, 2022Fracture; Fracture

  IT WAS REPORTED THE DRILL TIP FRACTURED WHEN THE SURGEON FIXED THE PLATE TO THE MANDIBLE. THE DEVICE WAS NOT LEFT IN THE PATIENT AND 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 15192245 ↗
• MalfunctionNov 30, 2020Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

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

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10917768 ↗
• MalfunctionFeb 19, 2020Fracture; Fracture

  IT WAS REPORTED THAT A DRILL BIT FRACTURED DURING SURGERY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9730206 ↗
• MalfunctionJan 17, 2020Fracture; Fracture

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9603688 ↗

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