Matrix 03.511.246Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10887587014289), received between Aug 24, 2018 and Feb 12, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024 DURING AN ORTHOGNATHIC PROCEDURE, THE SURGEON USED A DRILL TO INSERT A SCREW. HOWEVER, WHEN THEY TRIED TO INSERT THE SCREW IT SEEMED AS THOUGH THE HOLE WAS NOT LARGE ENOUGH FOR THE SCREW. A SECOND DRILL AND SECOND SCREW WERE TRIED BUT THE SAME RESULT OCCURRED. ON THE THIRD ATTEMPT IT WAS COMPLETED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE WAS NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A MATRIX 1.4MM DRILL BIT J-LATCH/6MM STOP/44.5MM. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18686059 ↗
• MalfunctionFeb 12, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2024 DURING AN ORTHOGNATHIC PROCEDURE, THE SURGEON USED A DRILL TO INSERT A SCREW. HOWEVER, WHEN THEY TRIED TO INSERT THE SCREW IT SEEMED AS THOUGH THE HOLE WAS NOT LARGE ENOUGH FOR THE SCREW. A SECOND DRILL AND SECOND SCREW WERE TRIED BUT THE SAME RESULT OCCURRED. ON THE THIRD ATTEMPT IT WAS COMPLETED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE WAS NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A MATRIX 1.4MM DRILL BIT J-LATCH/6MM STOP/44.5MM. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18686052 ↗
• MalfunctionOct 26, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIP PART OF THE INSTRUMENT WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE MATRIX 1.4MM DRILL BIT J-LATCH/6MM STOP/44.5MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15674937 ↗
• MalfunctionMar 1, 2021Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE, THREE (3) 1.5MM DRILL BIT WITH 8MM STOP, ONE (1) 1.5MM DRILL BIT WITH 6MM STOP, ONE (1) MATRIX DRILL BIT, AND ONE (1) 1.5MM 2 FLUTE DRILL BIT BROKE DURING AN UNKNOWN PROCEDURE. THE DRILL BITS DID NOT FIT PROPERLY THROUGH THE CUSTOMER CUTTING GUIDE FOR THE PATIENT SPECIFIC PLATES. THE DRILL FIT THROUGH WHEN PLACING THEM THROUGH BY HAND BUT IT WAS A TIGHT FIT RESULTING IN BURRING OF THE TITANIUM CUTTING GUIDE AND BREAKAGE OF THE DRILL BITS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A TRANSBUCCAL 1.5MM DRILL BIT. FRAGMENTS WERE GENERATED AND EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN CUTTING GUIDE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) MATRIX 1.4MM DRILL BIT J-LATCH/6MM STOP/44.5MM. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11394724 ↗
• 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 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8202882 ↗
• MalfunctionAug 24, 2018Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2018, THE TITANIUM (TI) MATRIX SCREW SELF-TAPPING WOULD NOT ENGAGE INTO THE PRE-DRILLED HOLE. A MATRIX DRILL BIT J-LATCH WAS USED TO PUT IN THE SCREW. IT IS UNKNOWN IF IT WAS AN ISSUE WITH THE SCREW OR THE DRILL BIT. ANOTHER UNKNOWN DRILL BIT AND UNKNOWN SCREW WERE USED, AND THEY WORKED FINE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY OR WHAT THE PATIENT OUTCOME WAS. THIS REPORT IS FOR A MATRIX 1.4MM DRILL BIT J-LATCH/6MM STOP/44.5MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

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

  MAUDE report 7813536 ↗

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