MatrixMANDIBLE 03.503.479Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10887587013008), received between May 3, 2017 and Mar 23, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Break; Entrapment of Device

  IT WAS REPORTED THE SURGEONS WERE IN AN OPEN REPAIR OF PARASYMPHYSEAL FRACTURE CASE. THE DOCTOR HAD USED THE DRILL BIT AND THE TIP BROKE AND UNFORTUNATELY STUCK ON THE MANDIBLE OF THE PATIENT. THE DOCTORS MENTIONED THAT THEY WOULD HAVE TO CRACK OPEN THE MANDIBLE TO RETRIEVE THE DRILL BIT. THE DOCTORS DID DISCLOSURE TO PATIENT AND DID THE NECESSARY DOCUMENTATION OF THE 2.5CM DRILL BIT TIP STUCK ON THE MANDIBLE. PROCEDURE WAS COMPLETED SUCCESSFULLY. THE FRAGMENT WAS LEFT IN SITU. SURGICAL DELAY WAS UNKNOWN

  Patient problems: Foreign Body In Patient

  MAUDE report 24665314 ↗
• MalfunctionJan 9, 2024Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLUMBIA AS FOLLOWS: IT WAS REPORTED DURING SURGERY ON (B)(6) 2023, A DRILL BIT BROKE DURING THE PROCEDURE, LEAVING THE TIP OF THIS INSIDE THE PATIENT. ANOTHER DRILL BIT WAS USED TO COMPLETE THE PROCEDURE. PROCEDURE COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THIS REPORT IS FOR ONE MATRIXMANDIBLE 1.5MM DRILL BIT MQC/125MM F/03.503.045/047 FOR (B)(4)

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18478131 ↗
• MalfunctionDec 26, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE DRILL BIT BROKE. THERE WERE OTHER DRILL BITS AVAILABLE, AND THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. THE PATIENT WAS NOT AFFECTED. THIS REPORT INVOLVES ONE MATRIXMANDIBLE 1.5MM DRILL BIT MQC/125MM F/03.503.045/047. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18394205 ↗
• MalfunctionJul 3, 2023Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLUMBIA AS FOLLOWS: IT WAS REPORTED DURING SURGERY ON (B)(6)2023, TWO (2) DRILL BITS DID NOT FIT WELL. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY OR HOW THE PROCEDURE WAS COMPLETED. CONCOMITANT DEVICE REPORTED: UNK - GUIDES/SLEEVES/AIMING (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN) THIS IS FOR ONE (1) MATRIXMANDIBLE 1.5MM DRILL BIT MQC/125MM F/03.503.045/047 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17248524 ↗
• MalfunctionJul 3, 2023Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLUMBIA AS FOLLOWS: IT WAS REPORTED DURING SURGERY ON (B)(6)2023, TWO (2) DRILL BITS DID NOT FIT WELL. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY OR HOW THE PROCEDURE WAS COMPLETED. CONCOMITANT DEVICE REPORTED: UNK - GUIDES/SLEEVES/AIMING (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN) THIS IS FOR ONE (1) MATRIXMANDIBLE 1.5MM DRILL BIT MQC/125MM F/03.503.045/047 FOR(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17248121 ↗
• MalfunctionJun 20, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE TWO DRILL BITS OF THE MENTIONED REFERENCE BROKE. THIS REPORT IS FOR ONE (1) DRILL BIT Ø1.5 F/MATMAND L125 2FLUTE F/0 THIS IS REPORT 2 OF 2 FOR COMPLAINT. (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17164670 ↗
• MalfunctionJun 20, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE TWO DRILL BITS OF THE MENTIONED REFERENCE BROKE. THIS REPORT IS FOR ONE (1) DRILL BIT Ø1.5 F/MATMAND L125 2FLUTE F/0. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17164666 ↗
• MalfunctionJan 12, 2022Break; Break

  DEVICE REPORT FROM SYNTHES COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THE DRILL BITS SPLIT DURING SURGERY. A PORTION OF ONE OF THEM WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR A DRILL BIT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13236479 ↗
• InjuryJan 11, 2022Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THE DRILL BITS SPLIT DURING SURGERY. A PORTION OF ONE OF THEM WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 13230096 ↗
• MalfunctionMay 3, 2017Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT IS REPORTED THE DRILL BIT WITH STOP WAS RECEIVED BROKEN. NO PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) DRILL BIT WITH STOP. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6540993 ↗
• MalfunctionMay 3, 2017Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT IS REPORTED THE DRILL BIT WITH STOP WAS RECEIVED BROKEN. NO PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) DRILL BIT WITH STOP. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6540954 ↗

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