MatrixMANDIBLE 03.503.412Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587012902), received between Apr 25, 2017 and Apr 27, 2017 — classified as 2 injuries.

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

• InjuryApr 27, 2017Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GLOSSECTOMY PROCEDURE ON (B)(6) 2017. WHILE USING THE ELECTRIC PEN DRIVE WITH A MATRIX MANDIBLE 1.5MM DRILL BIT ATTACHED TO DRILL INTO THE PATIENT'S MOUTH FOR PLACEMENT OF A SUTURE, THE DRILL BIT BROKE. ACCORDING TO THE SURGEON, APPROXIMATELY 10MM OF THE DRILL BIT WAS RETAINED IN THE PATIENT'S BONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER DRILL BIT AND NO DELAY IN SURGERY WAS REPORTED. THE SURGEON DID NOT ELECT TO ATTEMPT RETRIEVAL OF THE EMBEDDED PORTION OF THE DRILL BIT. PATIENT IS REPORTED IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED: ELECTRIC PEN DRIVE (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) MATRIX MANDIBLE 1.5MM DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6528401 ↗
• InjuryApr 25, 2017Break; Break

  IT WAS REPORT THAT THE PATIENT HAD SURGERY ON (B)(6) 2017 FOR AN UPPER MANDIBLE RECONSTRUCTION. PATIENT WAS IMPLANTED WITH ONE (1) UNKNOWN PLATE AND UNKNOWN QUANTITY/ TYPE OF SCREWS. AS THE SURGEON WAS DRILLING A PILOT HOLE INTO THE PATIENT¿S MANDIBLE FOR SCREW PLACEMENT, WHILE USING THE ELECTRIC PEN DRIVE WITH A MATRIX MANDIBLE 1.5MM DRILL BIT THE DRILL BIT BROKE. SURGEON REPORTED THAT 10MM OF THE DRILL BIT WAS LEFT IN THE PATIENT¿S MANDIBLE BONE. REMAINING PORTION OF THE DRILL BIT WAS RETAINED BY THE SALES CONSULTANT. SURGERY WAS SUCCESSFULLY COMPLETED WITH NO TIME DELAY. ANOTHER DRILL BIT WAS AVAILABLE IN THE OPERATING ROOM. PATIENT IS REPORTED IN STABLE CONDITION. SALES CONSULTANT HAS NO MORE INFORMATION TO REPORT ON THIS EVENT. THIS COMPLAINT INVOLVES 1 DEVICE. CONCOMITANT DEVICES REPORTED: ONE (1) PLATE (PART # UNKNOWN, LOT # UNKNOWN), UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), 1 ELECTRIC PEN DRIVE (PART # UNKNOWN, LOT # UNKNOWN) THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 6520765 ↗

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