MatrixMANDIBLE 03.503.561Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10887587013107), received between Jun 15, 2023 and Mar 6, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (5 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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2025Overheating of Device; Failure to Cut; Overheating of Device; Failure to Cut

  ADDITIONAL INFORMATION RECEIVED STATES THAT "THE DRILLS WERE USE IN A RABBIT STUDY IN YOUR PRECLINICAL FACILITY, WHERE WE CONDUCT TRANSLATIONAL IN VIVO STUDIES. THE PROCEDURE WAS PLATE OSTEOSYNTHESIS IN THE HUMERUS. THE ANIMALS IN YOUR CASES ARE NOT ¿PATIENTS¿ BUT ¿EXPERIMENTAL ANIMALS¿. HOWEVER, IT WAS NOT A TEST, BUT THE DRILL WAS USED IN A PROPERLY DESIGNED STUDY WITH A STUDY DESIGN. WE HAVE BEEN PERFORMING THIS HUMERUS OSTEOSYNTHESIS MODEL FOR YEARS NOW AND NEVER HAD A PROBLEM WITH THE DRILLS. SINCE THE DRILLS WE HAVE PREVIOUSLY USED ARE NOT MANUFACTURED ANY MORE, WE HAD TO ORDER DIFFERENT ONES, WITH WHICH THE PROBLEMS OCCURRED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21541561 ↗
• MalfunctionMar 6, 2025Overheating of Device; Failure to Cut; Overheating of Device; Failure to Cut

  ADDITIONAL INFORMATION RECEIVED STATES THAT "THE DRILLS WERE USE IN A RABBIT STUDY IN YOUR PRECLINICAL FACILITY, WHERE WE CONDUCT TRANSLATIONAL IN VIVO STUDIES. THE PROCEDURE WAS PLATE OSTEOSYNTHESIS IN THE HUMERUS. THE ANIMALS IN YOUR CASES ARE NOT ¿PATIENTS¿ BUT ¿EXPERIMENTAL ANIMALS¿. HOWEVER, IT WAS NOT A TEST, BUT THE DRILL WAS USED IN A PROPERLY DESIGNED STUDY WITH A STUDY DESIGN. WE HAVE BEEN PERFORMING THIS HUMERUS OSTEOSYNTHESIS MODEL FOR YEARS NOW AND NEVER HAD A PROBLEM WITH THE DRILLS. SINCE THE DRILLS WE HAVE PREVIOUSLY USED ARE NOT MANUFACTURED ANY MORE, WE HAD TO ORDER DIFFERENT ONES, WITH WHICH THE PROBLEMS OCCURRED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21541558 ↗
• MalfunctionMar 6, 2025Overheating of Device; Failure to Cut; Overheating of Device; Failure to Cut

  IT WAS REPORTED FIVE DRILLS IN TOTAL WAS USED DURING A PROCEDURE ON (B)(6) 2025. SURGEON DRILLED 6 HOLES. THE FIRST HOLE WAS GREAT TO DRILL, THE SECOND WAS GREAT, BUT IT TOOK A LITTLE LONGER FOR THE TWO CORTICES TO DRILL, BUT THE THIRD HOLE WAS BLUNT AND IT TOOK A LONG TIME FOR THE FIRST CORTEX TO BE DRILLED. THIS THEN ALSO AFFECTS THE DRILL HANDSET, WHICH IS HOT. TWO DRILLS ALSO DID NOT ROTATE HOMOGENEOUSLY AND WERE A BIT STIFF. HOWEVER, IT MAY BE THAT THIS WAS PARTLY DUE TO THE COUPLING. ALL DRILL BITS WERE GOING DULL. PROCEDURE WAS COMPLETED SUCCESSFULLY. ANOTHER DRILL BIT WAS USED. UNKNOWN SURGICAL DELAY. NO PATIENT WAS INVOLVED AS IT WAS A RABBIT TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21541552 ↗
• MalfunctionMar 6, 2025Overheating of Device; Failure to Cut; Overheating of Device; Failure to Cut

  ADDITIONAL INFORMATION RECEIVED STATES THAT "THE DRILLS WERE USE IN A RABBIT STUDY IN YOUR PRECLINICAL FACILITY, WHERE WE CONDUCT TRANSLATIONAL IN VIVO STUDIES. THE PROCEDURE WAS PLATE OSTEOSYNTHESIS IN THE HUMERUS. THE ANIMALS IN YOUR CASES ARE NOT ¿PATIENTS¿ BUT ¿EXPERIMENTAL ANIMALS¿. HOWEVER, IT WAS NOT A TEST, BUT THE DRILL WAS USED IN A PROPERLY DESIGNED STUDY WITH A STUDY DESIGN. WE HAVE BEEN PERFORMING THIS HUMERUS OSTEOSYNTHESIS MODEL FOR YEARS NOW AND NEVER HAD A PROBLEM WITH THE DRILLS. SINCE THE DRILLS WE HAVE PREVIOUSLY USED ARE NOT MANUFACTURED ANY MORE, WE HAD TO ORDER DIFFERENT ONES, WITH WHICH THE PROBLEMS OCCURRED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21541544 ↗
• MalfunctionMar 6, 2025Overheating of Device; Failure to Cut; Overheating of Device; Failure to Cut

  IT WAS REPORTED FIVE DRILLS IN TOTAL WAS USED DURING A PROCEDURE ON (B)(6) 2025 SURGEON DRILLED 6 HOLES. THE FIRST HOLE WAS GREAT TO DRILL, THE SECOND WAS GREAT, BUT IT TOOK A LITTLE LONGER FOR THE TWO CORTICES TO DRILL, BUT THE THIRD HOLE WAS BLUNT AND IT TOOK A LONG TIME FOR THE FIRST CORTEX TO BE DRILLED. THIS THEN ALSO AFFECTS THE DRILL HANDSET, WHICH IS HOT. TWO DRILLS ALSO DID NOT ROTATE HOMOGENEOUSLY AND WERE A BIT STIFF. HOWEVER, IT MAY BE THAT THIS WAS PARTLY DUE TO THE COUPLING. ALL DRILL BITS WERE GOING DULL. PROCEDURE WAS COMPLETED SUCCESSFULLY. ANOTHER DRILL BIT WAS USED. UNKNOWN SURGICAL DELAY. NO PATIENT WAS INVOLVED AS IT WAS A RABBIT TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21541525 ↗
• MalfunctionJun 15, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT THE DRILL BIT BROKE ON MAY 26, 2023. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE 1.8MM DRILL BIT MQC/90MM FOR 03.503.044. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17133208 ↗

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-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-2783-2016 · Jun 24, 2016 · Terminated
  Light Adaptor for Small Battery Drive and Small Battery Drive II.
• 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