Matrix 03.511.252Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887587014302), received between Oct 12, 2020 and May 27, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 27, 2026Break; Entrapment of Device

  IT WAS REPORTED DURING A LEFORT I PROCEDURE ON (B)(6) 2025, A DRILL BIT FRACTURED INTRAOPERATIVELY. THE BROKEN FRAGMENT COULD NOT BE LOCATED BY THE SURGICAL TEAM DURING THE PROCEDURE. AN X-RAY PERFORMED AT THE END OF THE CASE CONFIRMED THAT A PORTION OF THE DRILL BIT HAD BEEN RETAINED WITHIN THE PATIENT¿S FACIAL TISSUES.

  Patient problems: Foreign Body In Patient

  MAUDE report 25302997 ↗
• 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 DB J-LATCH/12 STOP/44.5. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15298057 ↗
• 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/12MM STOP/44.5MM. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10666690 ↗

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