Matrix 03.511.343Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587014456), received between Feb 21, 2018 and Feb 21, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2018Break; Break

  IT WAS REPORTED THAT A MATRIX 1.4 MM DRILL BIT/J-LATCH CALIBRATED F/BASIC TROCAR SYSTEM BROKE INTO THREE PIECES DURING A MANDIBULAR OSTEOTOMY ON (B)(6) 2018. THERE WAS A TWENTY-MINUTE SURGICAL DELAY RELATED TO RETRIEVING THE BROKEN FRAGMENTS FROM THE PATIENT'S BONE. ALL FRAGMENTS WERE RETRIEVED. NO X-RAYS ARE AVAILABLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM. THIS REPORT IS FOR ONE (1) MATRIX 1.4 MM DRILL BIT/J-LATCH CALIBRATED F/BASIC TROCAR SYS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7286564 ↗

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