MatrixMANDIBLE 03.503.461Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887587012933), received between Sep 3, 2020 and Sep 18, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Defective Device” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2023Defective Device; Device-Device Incompatibility; Defective Device; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2023, THAT THE PROPLAN GUIDE FOR THE CASE RECOMMENDED A 1.8 DRILL BIT WITH THE DRILL GUIDE FOR THE PRE-DRILL CYLINDERS. THEY HAD OPENED A 1.8 DRILL AND THIS GUIDE. WHEN WE MOUNTED THE DRILL ON THE POWER TOOL (THEY USE A STRYKER HANDPIECE, IF THIS IS RELEVANT), THERE SEEMED TO BE A LOT OF TOGGLE ON THE DRILL BIT WITHOUT A GUIDE BEFORE INSERTING INTO THE TEMPLATE, AND ALSO THE DRILL BIT WAS FAR TOO SHORT WITH THE DRILL GUIDE. SOME OF THESE SCREWS RECOMMENDED WERE 16MM AND 18MM IN LENGTH, AND IF YOU LOOKED AT THE LENGTH OF THE DRILL WHEN PLACED INTO THE GUIDE, IT LOOKED LIKE THE DRILLING LENGTH WOULD REACH A MAXIMUM OF 10MM. THE TWO SURGEONS INVOLVED IN THE CASE WERE UNHAPPY WITH THE AMOUNT OF TOGGLE FIRST ON THE DRILL AND ALSO THAT THE LENGTH DIDN¿T REACH LONG ENOUGH WHEN USING THE GUIDE. THE CASE WENT WELL ENOUGH APART FROM THESE ISSUES. UNFORTUNATELY, THE TUMOR HAD EXTENDED INTO THE MANDIBLE. SO IT HAD TO FREEHAND SOME OF THE LEFT SIDE OF THE MANDIBLE. THE SURGEON MANAGED TO UTILIZE TWO OF THE SCREW HOLES ON THIS SIDE THROUGH THE GUIDE BUT THEN HAD TO BRING IN SOME EXTRA FIBULA AND BURR THE BONE TO ADAPT TO THE PLATE. THERE WERE A FEW MINUTES OF SURGICAL D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17765797 ↗
• MalfunctionSep 18, 2023Defective Device; Device-Device Incompatibility; Defective Device; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2023, THAT THE PROPLAN GUIDE FOR THE CASE RECOMMENDED A 1.8 DRILL BIT WITH THE DRILL GUIDE FOR THE PRE-DRILL CYLINDERS. THEY HAD OPENED A 1.8 DRILL AND THIS GUIDE. WHEN WE MOUNTED THE DRILL ON THE POWER TOOL (THEY USE A STRYKER HANDPIECE, IF THIS IS RELEVANT), THERE SEEMED TO BE A LOT OF TOGGLE ON THE DRILL BIT WITHOUT A GUIDE BEFORE INSERTING INTO THE TEMPLATE, AND ALSO THE DRILL BIT WAS FAR TOO SHORT WITH THE DRILL GUIDE. SOME OF THESE SCREWS RECOMMENDED WERE 16MM AND 18MM IN LENGTH, AND IF YOU LOOKED AT THE LENGTH OF THE DRILL WHEN PLACED INTO THE GUIDE, IT LOOKED LIKE THE DRILLING LENGTH WOULD REACH A MAXIMUM OF 10MM. THE TWO SURGEONS INVOLVED IN THE CASE WERE UNHAPPY WITH THE AMOUNT OF TOGGLE FIRST ON THE DRILL AND ALSO THAT THE LENGTH DIDN¿T REACH LONG ENOUGH WHEN USING THE GUIDE. THE CASE WENT WELL ENOUGH APART FROM THESE ISSUES. UNFORTUNATELY, THE TUMOR HAD EXTENDED INTO THE MANDIBLE. SO IT HAD TO FREEHAND SOME OF THE LEFT SIDE OF THE MANDIBLE. THE SURGEON MANAGED TO UTILIZE TWO OF THE SCREW HOLES ON THIS SIDE THROUGH THE GUIDE BUT THEN HAD TO BRING IN SOME EXTRA FIBULA AND BURR THE BONE TO ADAPT TO THE PLATE. THERE WERE A FEW MINUTES OF SURGICAL D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17765778 ↗
• MalfunctionSep 3, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING A MANDIBLE RECONSTRUCTION PROCEDURE THE DRILL BIT BROKE WHEN THE BIT WAS PLACED IN THE DRILL. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. FRAGMENTS WERE GENERATED AND EASILY REMOVED. ANOTHER DRILL BIT WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICE REPORTED: DRILL (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) MATRIXMANDIBLE 1.8MM DRILL BIT J-LATCH/90MM FOR 03.503.044. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10488365 ↗

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