Matrix 03.511.248Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10887587014296), received between Oct 12, 2020 and Jul 26, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 26, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON JULY 5, 2024, A DRILL BIT BROKE INTO 2 PIECES DURING A SURGERY AND A 5MM TIP WAS LEFT INSIDE THE PATIENT AS FOREIGN BODY. THE PATIENT WAS ORIGINALLY SCHEDULED TO UNDERGO AN MRI, HOWEVER, DUE TO THE DRILL BIT TIP LEFT IN THE PATIENT'S BONE, IT IS IMPOSSIBLE FOR THE PATIENT TO PROCEED WITH THE MRI. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) MATRIX 1.4MM DRILL BIT J-LATCH/8MM STOP/44.5MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 19840837 ↗
• MalfunctionDec 21, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, A 03.511.248 DRILL BIT WAS FOUND TO BE BLUNT BY SURGEON. THERE WAS NO NEGATIVE PATIENT OUTCOME, AND THE SURGERY WAS NOT DELAYED DUE TO THE EVENT. A REPLACEMENT DRILL BIT WAS USED FROM THE SET, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER MEDICAL INTERVENTION WAS NECESSARY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE MATRIX 1.4MM DRILL BIT J-LATCH/8MM STOP/44.5MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16021990 ↗
• MalfunctionAug 25, 2022Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, DURING THE CASE, TWO DRILL BITS BROKE OFF IN THE MIDDLE OF IT WHILE PERFORMING SURGERY ON THE PATIENT. PATIENT OUTCOME WAS UNKNOWN. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) MATRIX 1.4 DRILL BIT J-LATCH/8 STOP/44.5. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15298025 ↗
• MalfunctionJun 7, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT 1 X (LOAN SET) 03.511.248 DRILL BIT ARRIVED BLUNT AND DIRTY FOR A CASE. DRILL BIT NOT FIT FOR PURPOSE AND THEREFORE DISPOSED OF PRIOR TO STERILIZATION. THIS REPORT IS FOR ONE (1) MATRIX DRILL BIT Ø1.4 W/STOP L44.5/8. THIS IS REPORT 1 OF 1 FOR COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14626454 ↗
• MalfunctionApr 28, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A CUSTOMER RECEIVED LOAN AN ORTHOGNATHIC SET AND DURING THE CHECK IN PROCESS, IT WAS DISCOVERED THAT THERE WERE TWO DIRTY DRILL BITS IN THE SET (DRILL BIT #1: MATRIX 1.4MM DRILL BIT J-LATCH/8MM STOP/44.5MM, DRILL BIT #2 DRILL BIT Ø1.5 W/STOP L44.5/8 2FLUTE). BOTH DRILL BITS WERE REMOVED AND QUARANTINED BY LOANS STAFF AND PUT ASIDE FOR FURTHER ADVICE ON WHAT TO DO WITH THEM. THERE WERE ADDITIONAL DRILL BITS IN THE SET SO THE CASE WAS ABLE TO BE COMPLETED. THIS REPORT IS FOR THE MATRIX 1.4MM DRILL BIT J-LATCH/8MM STOP/44.5MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14240291 ↗
• MalfunctionJan 4, 2021Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 WHILST USING THE TRUMATCH MANDIBLE CUTTING GUIDE, TWO (2) DRILL BITS FAILED IN THE DRILL TOWER. THE TOLERANCES IN THE DRILL TOWER ARE TOO TIGHT AND IMPEDE THE DRILL BIT. THE DRILL TOWER IS INTEGRATED IN THE CUTTING GUIDE, CAUSING THE DAMAGE. THE ONE SNAPPED AND ONE WAS WORN DOWN AND APPEARED TO RECEIVE THERMAL DAMAGE. ONCE THE CUTTING GUIDE WAS REMOVED, FURTHER DRILLING WAS PERFORMED UNGUIDED TO COMPLETE THE SURGERY SUCCESSFULLY. THIS REPORT IS FOR ONE (1) MATRIX 1.4MM DRILL BIT J-LATCH/8MM STOP/44.5MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11108463 ↗
• MalfunctionJan 4, 2021Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 WHILST USING THE TRUMATCH MANDIBLE CUTTING GUIDE, TWO (2) DRILL BITS FAILED IN THE DRILL TOWER. THE TOLERANCES IN THE DRILL TOWER ARE TOO TIGHT AND IMPEDE THE DRILL BIT. THE DRILL TOWER IS INTEGRATED IN THE CUTTING GUIDE, CAUSING THE DAMAGE. THE ONE SNAPPED AND ONE WAS WORN DOWN AND APPEARED TO RECEIVE THERMAL DAMAGE. ONCE THE CUTTING GUIDE WAS REMOVED, FURTHER DRILLING WAS PERFORMED UNGUIDED TO COMPLETE THE SURGERY SUCCESSFULLY. THIS REPORT IS FOR ONE (1) MATRIX 1.4MM DRILL BIT J-LATCH/8MM STOP/44.5MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11108444 ↗
• MalfunctionOct 12, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN ORTHOGNATHIC PROCEDURE, THREE (3) MATRIX 1.4MM DRILL BIT J-LATCH/8MM STOP/44.5MM AND ONE (1) MATRIX 1.4MM DRILL BIT J-LATCH/12MM STOP/44.5MM WERE BROKEN WHILE DRILLING THROUGH CUSTOM GUIDES. THE DOCTOR WAS ABLE TO USE A DIFFERENT LENGTH DRILL BIT TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO SURGICAL DELAY. IT IS UNKNOWN IF THERE WERE FRAGMENTS GENERATED. NO PATIENT CONSEQUENCES REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN DRILL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) MATRIX 1.4MM DRILL BIT J-LATCH/8MM STOP/44.5MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10666697 ↗
• MalfunctionOct 12, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN ORTHOGNATHIC PROCEDURE, THREE (3) MATRIX 1.4MM DRILL BIT J-LATCH/8MM STOP/44.5MM AND ONE (1) MATRIX 1.4MM DRILL BIT J-LATCH/12MM STOP/44.5MM WERE BROKEN WHILE DRILLING THROUGH CUSTOM GUIDES. THE DOCTOR WAS ABLE TO USE A DIFFERENT LENGTH DRILL BIT TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO SURGICAL DELAY. IT IS UNKNOWN IF THERE WERE FRAGMENTS GENERATED. NO PATIENT CONSEQUENCES REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN DRILL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) MATRIX 1.4MM DRILL BIT J-LATCH/8MM STOP/44.5MM. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10666662 ↗
• MalfunctionOct 12, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN ORTHOGNATHIC PROCEDURE, THREE (3) MATRIX 1.4MM DRILL BIT J-LATCH/8MM STOP/44.5MM AND ONE (1) MATRIX 1.4MM DRILL BIT J-LATCH/12MM STOP/44.5MM WERE BROKEN WHILE DRILLING THROUGH CUSTOM GUIDES. THE DOCTOR WAS ABLE TO USE A DIFFERENT LENGTH DRILL BIT TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO SURGICAL DELAY. IT IS UNKNOWN IF THERE WERE FRAGMENTS GENERATED. NO PATIENT CONSEQUENCES REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN DRILL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) MATRIX 1.4MM DRILL BIT J-LATCH/8MM STOP/44.5MM. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10666644 ↗

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