MatrixMANDIBLE 03.503.471Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887587012957), received between Jan 13, 2021 and May 18, 2022 — classified as 3 malfunctions.

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

• MalfunctionMay 18, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT THIS WAS A MANDIBULAR RECONSTRUCTION SURGERY USING MATRIX MANDIBLE RECON IMPLANTS WITH THE DRILL BIT IN QUESTION. IN THE SURGERY, THE DRILL BIT WAS BROKEN WHILE MAKING A LOWER HOLE IN THE MANDIBLE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR (1) DRILL BIT Ø2.4 L90 F/03.503.046. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14427790 ↗
• MalfunctionMar 3, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THIS WAS A RECONSTRUCTION PROCEDURE IN THE MANDIBLE ON (B)(6) 2022. THEY WERE SUPPOSED TO SELECT A 1.8MM DRILL BIT. HOWEVER, THE SURGEON DID NOT RECOGNIZE THAT HE HAD MISTAKENLY PICKED OUT THE 2.4MM DRILL BIT IN QUESTION. SINCE APPROXIMATELY FOUR TO FIVE BURR HOLES WERE MADE WITH THE DRILL BIT IN QUESTION, 2.4MM SCREWS DID NOT FIT INTO THOSE LARGER BURR HOLES. THE PROCEDURE WAS COMPLETED WITH 2.7MM REPLACING SCREWS LESS THAN 30-MINUTE SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE DRILL BIT Ø2.4 L90 F/03.503.046. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13659056 ↗
• MalfunctionJan 13, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THIS PATIENT UNDERWENT SURGERY ON (B)(6) 2020 TO REPLACE A MANDIBULAR PLATE, TREATING MANDIBULAR OSTEOMYELITIS. THE SURGEON TRIED TO ATTACH THE DRILL BIT TO THE DRILL. BUT THE DRILL BIT DID NOT GO THROUGH THE DRILL¿S INLET. THE PROCEDURE WAS COMPLETED WITH LESS THAN THIRTY (30) MINUTES DELAY. PATIENT WAS STABLE. THIS REPORT IS FOR A MATRIXMANDIBLE 2.4MM DRILL BIT J-LATCH. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11167002 ↗

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