MatrixMANDIBLE 03.503.477Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587012988), received between Sep 15, 2022 and Jul 28, 2025 — classified as 2 malfunctions.

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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT MANDIBULAR TUMOR REMOVAL SURGERY. WHEN THE SURGEON DRILLED A BURR HOLE IN THE MANDIBLE FOR INSERTING A SCREW, THE COLOR CODE (LIGHT BLUE) OF THE DEVICE PEELED OFF. THE DETACHED FRAGMENTS WERE REMOVED FROM THE BODY, AND IT IS UNLIKELY THAT ANY FRAGMENTS REMAIN INSIDE THE BODY. THE SURGEON IS OF THE OPINION THAT NO DETACHED FRAGMENTS REMAIN INSIDE THE BODY. THERE WAS NO PROBLEM WITH THE DRILLING FUNCTION OF THE DEVICE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22629311 ↗
• MalfunctionSep 15, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022 WHILE IN A CASE AT THE HOSPITAL, A DRILL BIT BROKE OFF IN THE PATIENT MANDIBLE. THIS REPORT IS FOR ONE (1) MATRIXMND 1.8 DB J-LATCH 03.503.045/.047 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15431002 ↗

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