MatrixMANDIBLE 03.503.451Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10887587012919), received between Sep 14, 2020 and Oct 9, 2023 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2023, THE PATIENT UNDERWENT AN ORIF SURGERY TREATING A MANDIBULAR FRACTURE. DURING THE PROCEDURE WHILE USING THE DRILL SLEEVE, IT BECAME HOT AND CAUSE BURNS ON THE PATIENT¿S ORAL MUCOSA. WHEN THE DRILL BIT WAS REMOVED FROM THE SLEEVE, IT WAS FOUND THAT THE DRILL BIT WAS DAMAGED IN THE MIDDLE SECTION. IT WAS CONCLUDED THAT THE DRILL BIT WAS BEING HELD AGAINST THE SLEEVE, WHICH GENERATED HEAD DUE TO ROTATIONAL FRICTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE PATIENT EXPERIENCED SOME BURNS IN THEIR MOUTH BUT IS IN A STABLE CONDITION, NO PROBLEMS HAVE BEEN OBSERVED. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH/90MM FOR 03.503.043. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Burn(s)

  MAUDE report 17896245 ↗
• MalfunctionApr 4, 2023Break; Failure to Cut; Break; Failure to Cut

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE DRILL BITS IN QUESTION WERE CUTTING POORLY AND BROKE DURING SURGERY. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH/90MM FOR 03.503.043. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16675437 ↗
• MalfunctionApr 4, 2023Break; Failure to Cut; Break; Failure to Cut

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2023, THE DRILL BITS IN QUESTION WERE CUTTING POORLY AND BROKE DURING SURGERY. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH/90MM FOR 03.503.043. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16675430 ↗
• MalfunctionJan 12, 2023Break; Break

  DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE DRILL BIT IN QUESTION WAS FOUND TO BE BROKEN. THERE WERE NO REPORTED ADVERSE PATIENT OUTCOMES, THE EVENT DID NOT OCCUR INTRA-OP. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH/90MM FOR 03.503.043. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16152363 ↗
• MalfunctionDec 15, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING A MANDIBULAR RAMUS FX OSTEOSYNTHESIS AND LEFT MAXILLARY CONDYLE OSTEOTOMY THAT THE DRILL BROKE INTRAOPERATIVELY. THERE WAS NO HARM TO THE PATIENT. THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH/90MM FOR 03.503.043. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11012055 ↗
• InjurySep 14, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2020, A DRILL BIT BROKE OFF INSIDE THE PATIENT'S MANDIBLE AND WAS RETAINED. THERE WAS NO SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS WERE UNKNOWN. THIS REPORT IS FOR ONE (1) MATRIX MANDIBLE 1.5MM DRILL BIT J-LATCH/ 90MM FOR 03.503.043. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Injury

  MAUDE report 10529224 ↗

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