TOTAL MANDIBULAR SYSTEM 24-2050Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00841036059279), received between Apr 17, 2020 and Jul 8, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INITIAL PROCEDURE, TWO (2) DRILL BITS FRACTURED. A THIRD DRILL BIT WAS UTILIZED TO COMPLETE THE PROCEDURE. ALL FRACTURED FRAGMENTS WERE RECOVERED. THE SURGICAL TECHNIQUE SPECIFIED FOR THIS DEVICE WAS FOLLOWED. THE DRILL BITS HAD BEEN USED MULTIPLE TIMES. NO PATIENT INJURY OR DELAY TO THE PROCEDURE WAS REPORTED AS A RESULT OF THIS MALFUNCTION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22437463 ↗
• MalfunctionJul 8, 2025Fracture; Fracture

  IT WAS REPORTED DURING THE PROCEDURE, THAT TWO (2) DRILL BITS FRACTURED DURING USE. A THIRD DRILL BIT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY OR DELAY IN PROCEDURE AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22437451 ↗
• MalfunctionDec 21, 2020Fracture; Fracture

  IT WAS REPORTED THAT TWO (2) DRILL BITS FRACTURED DURING A MANDIBULAR PROCEDURE. THE SURGEON REPORTED THE INSTRUMENTS SHOOK DURING ROTATION. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

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

  MAUDE report 11051099 ↗
• MalfunctionDec 21, 2020Fracture; Fracture

  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 11051060 ↗
• MalfunctionDec 13, 2020Fracture; Fracture

  IT WAS REPORTED THE DRILL TIP BROKE WHEN THE SURGEON TRIED TO DRILL A PILOT HOLE DURING A MANDIBULAR RECONSTRUCTION SURGERY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DRILL BIT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

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

  MAUDE report 10999094 ↗
• MalfunctionJun 4, 2020Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT ONE DRILL BIT FRACTURED AND ONE DRILL BIT BENT DURING A PROCEDURE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10120179 ↗
• MalfunctionApr 17, 2020Fracture; Fracture

  IT WAS REPORTED THE DRILL BIT FRACTURED WHILE PREPARING A PILOT HOLE. THE FRAGMENT OF THE DRILL BIT WAS REMOVED FROM THE PATIENT'S BONE WITH FORCEPS. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DRILL BIT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9972621 ↗

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