MatrixMANDIBLE 03.503.408Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10887587012889), received between Dec 28, 2018 and Sep 16, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

6 other recalls cover devices cleared under the same FDA submission (K043310); 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.

• MalfunctionSep 16, 2025Break; Break

  DURING THE PROCEDURE, WHILE THE SPECIALIST WAS PERFORMING THE DRILLING, THE DRILL BIT BROKE. THE DRILL BIT ALONG WITH ITS FRAGMENTS WERE REMOVED. ANOTHER DRILL BIT WITH THE SAME CHARACTERISTICS WAS PASSED TO THE DOCTOR, THUS SUCCESSFULLY COMPLETING THE SURGERY. THERE WAS NO HARM TO THE PATIENT AND THERE WERE NO ALTERATIONS IN SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23066891 ↗
• MalfunctionFeb 29, 2024Break; Failure to Cut; Break; Failure to Cut

  THE SURGERY WAS COMPLETED SUCCESSFULLY. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED AND THE PATIENT OUTCOME WAS REPORTED TO BE STABLE.

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

  MAUDE report 18807715 ↗
• MalfunctionFeb 29, 2024Break; Failure to Cut; Break; Failure to Cut

  THE SURGERY WAS COMPLETED SUCCESSFULLY. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED AND THE PATIENT OUTCOME WAS REPORTED TO BE STABLE.

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

  MAUDE report 18807713 ↗
• MalfunctionOct 4, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRILL BIT WAS BROKEN. IT IS UNKNOWN IF THERE WAS SURGICAL OR PATIENT INVOLVEMENT. NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH W/8MM STOP/50MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12569835 ↗
• MalfunctionFeb 4, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, THE 1.5MM DRILL BIT WAS USED TO FIX THE 2.0 SCREWS TO THE PLATE, HOWEVER 1.5MM DRILL BIT WAS DULL. ANOTHER DRILL BIT OF THE SAME DIAMETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY REPORTED AND THERE WAS NO HARM OR ADVERSE EVENT TO THE PATIENT. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWS (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH W/8MM STOP/50MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11282067 ↗
• MalfunctionJan 17, 2020Failure to Cut; Failure to Cut

  UPDATE: THIS REPORT IS 1 OF 6 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9604480 ↗
• MalfunctionDec 28, 2018Overheating of Device; Overheating of Device

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, DURING THE INTER-MOLAR DISTRACTION OSTEOGENESIS (IMDO) PROCEDURE, TWO (2) TRUMATCH MANDIBLE GUIDE WERE HEATING UP DURING PRE-DRILLING. THE CYLINDER AND GUIDES WERE HEATING UP DUE TO THE DRILL. IT WAS NOTED THREE (3) DRILL BITS WERE TOUCHING THE CYLINDER BECAUSE OF THE ANGULATION OF THE GUIDE. THERE WAS NO SURGICAL DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT AND THERE WAS NO ISSUE WITH THE PLATES OR SCREWS. CONCOMITANT DEVICES REPORTED: MANDIBLE PLATE (PART/LOT UNKNOWN, QUANTITY UNKNOWN), MANDIBLE SCREW (PART/LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR A DRILL BIT. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8202839 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K043310. One submission often covers many models, so check the product and lot details in each record.

• Z-0681-2017 · Nov 1, 2016 · Terminated
  Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile
• Z-2783-2016 · Jun 24, 2016 · Terminated
  Light Adaptor for Small Battery Drive and Small Battery Drive II.
• Z-2784-2016 · Jun 24, 2016 · Terminated
  Adaptor for Small Battery Drive and Small Battery Drive II. Product Usage: The Light Adaptor for Small Battery Drive (SBD) /Small Battery Drive II (SBD II) is designed for use in
• Z-2199-2016 · May 31, 2016 · Terminated
  Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989, mfg. 9/28/2001 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments ar
• Z-1313-2015 · Dec 19, 2014 · Terminated
  Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticati
• Z-0615-2014 · Apr 15, 2013 · Terminated
  Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and met