MatrixMANDIBLE 03.503.476Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10887587012971), received between Apr 13, 2018 and Feb 8, 2024 — classified as 13 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 8, 2024Break; Break

  THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 18671103 ↗
• MalfunctionDec 4, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLUMBIA AS FOLLOWS: IT WAS REPORTED DURING SURGERY ON (B)(6) 2023, IT IS EVIDENT THAT THE MATRIXMANDIBLE 1.5 DRILL BIT DOES NOT CUT BECAUSE IT TAKES A LONG TIME TO PASS THE CORTICES OF THE BONE. THE SURGERY WAS DELAYED FOR A FEW SECONDS WHILE THE DRILL BIT WAS CHANGED OUT. THE SECOND DRILL THAT WAS PASSED ALSO TOOK A LONG TIME TO PASS IN THE BONE. IT IS RESOLVED BY CHANGING OUT TO A THIRD DRILL. THE SURGERY IS COMPLETED SUCCESSFULLY ACHIEVED. THIS REPORT IS FOR MATRIXMND 1.5 DB J-LATCH 03.503.045/.047 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18257206 ↗
• MalfunctionNov 28, 2023Break; Break

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE SCRUB NURSE LOADED THE DRILL BIT INTO THE HANDPIECE AND TESTED THE DRILL OUTSIDE OF THE PATIENT. THE TIP OF THE DRILL BIT FLEW OFF ACROSS THE ROOM AND LANDED ON THE FLOOR. A NEW DRILL BIT WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH 2 MINUTES OF SURGICAL DELAY. ALL GENERATED FRAGMENTS WERE OUTSIDE OF THE PATIENT AND COLLECTED WITHOUT ADDITIONAL MEDICAL INTERVENTION. THERE WAS NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH FOR 03.503.045/.047. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18222078 ↗
• InjuryAug 7, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT DURING THE MANDIBULAR RAMUS FIXATION SURGERY ON (B)(6) 2023, WHILE USING THE TRANSBUCCAL GUIDE, THE 1.5 DRILL BIT WAS DETERIORATED AS IT WAS BLUNT. THEREFORE THE SPECIALIST EXERT PRESSURE ON THE MOTOR, WHICH CAUSED THE DRILL BIT TO BREAK AND A FRAGMENT REMAINED IN THE MANDIBULAR BONE. THE FRAGMENTS THAT WERE MANAGED TO EXTRACT ARE LEFT IN THE EQUIPMENT WITH RED TAPE. THERE WAS UNKNOWN AMOUNT OF SURGICAL DELAY. THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH FOR 03.503.045/.047. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 17470862 ↗
• MalfunctionApr 20, 2023Break; Break

  SURGERY WAS COMPLETED SUCCESSFULLY AND WAS NOT DELAYED DUE TO THE INCIDENT. THE PATIENT OUTCOME WAS REPORTED TO BE OPTIMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16782321 ↗
• MalfunctionApr 7, 2023Break; Break

  IT WAS REPORTED THAT A MATRIX MANDIBLE DRILL BIT BROKE DURING SURGERY. THERE WERE NO DELAY, A NEW BIT WAS USED, AND FRAGMENTS REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) MATRIXMND 1.5 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 16703374 ↗
• MalfunctionMar 8, 2023Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE DRILL BIT IN QUESTION FRACTURED. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH FOR 03.503.045/.047. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16504583 ↗
• InjuryJan 24, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE DRILL BIT FRACTURED DURING SURGERY, LEAVING A FRAGMENT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT STATUS/OUTCOME WAS REPORTED TO BE OK. THERE WAS NO DELAY IN SURGERY DUE TO THE EVENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH FOR 03.503.045/.047. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 16232892 ↗
• InjuryJul 15, 2021Overheating of Device; Material Deformation; Overheating of Device; Material Deformation

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THAT THE DRILL BIT BENT AND CAUSED BURNS TO THE PATIENT. TWO (2) OTHER DRILL BITS WERE TRIED AND DID NOT BEND BUT HEATED TO A POINT OF CAUSING THE BURNS, UPON INSPECTION IT SEEMS THAT THE DRILL SLEEVE HAS A SLIGHT BEND IN IT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH FOR 03.503.045/.047. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Burn(s)

  MAUDE report 12176086 ↗
• InjuryJul 15, 2021Overheating of Device; Material Deformation; Overheating of Device; Material Deformation

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THAT THE DRILL BIT BENT AND CAUSED BURNS TO THE PATIENT. TWO (2) OTHER DRILL BITS WERE TRIED AND DID NOT BEND BUT HEATED TO A POINT OF CAUSING THE BURNS, UPON INSPECTION IT SEEMS THAT THE DRILL SLEEVE HAS A SLIGHT BEND IN IT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH FOR 03.503.045/.047. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Burn(s)

  MAUDE report 12175976 ↗
• InjuryJul 15, 2021Failure to Cut; Material Deformation; Failure to Cut; Material Deformation

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B(6) 2021 THAT THE DRILL BIT BENT AND CAUSED BURNS TO THE PATIENT. TWO (2) OTHER DRILL BITS WERE TRIED AND DID NOT BEND BUT HEATED TO A POINT OF CAUSING THE BURNS, UPON INSPECTION IT SEEMS THAT THE DRILL SLEEVE HAS A SLIGHT BEND IN IT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH FOR 03.503.045/.047. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Burn(s)

  MAUDE report 12175858 ↗
• InjuryJun 1, 2021Break; Break

  IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) BILATERAL MANDIBLE FRACTURE ON (B)(6) 2021, THE DRILL BIT BROKE WHILE DRILLING TO PLACE A SCREW. INTRAORAL INCISION WAS EXTENDED TO RETRIEVE THE BROKEN TIP OF THE BRILL BIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A FIFTEEN (15) MINUTE DELAY. THERE WERE NO OTHER PATIENT CONSEQUENCES. THIS REPORT IS FOR A MATRIXMANDIBLE 1.5MM DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11916089 ↗
• MalfunctionMar 8, 2021Overheating of Device; Overheating of Device

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A DRILL BIT AND CANNULA WAS HEATING UP, AS DESCRIBED IN PREVIOUS PRODUCT COMPLAINT: (B)(4) . SEE (B)(4) FOR DETAILS AS DESCRIBE ORTHOGNATHIC. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ONLY A TWO MINUTE DELAY. THIS REPORT IS FOR ONE MATRIXMANDIBLE DRILL BIT ¿1.5 2FLUTE F/0. THIS COMPLAINT INVOLVES TWO DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11435449 ↗
• MalfunctionMar 2, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, THE MATRIXMANDIBLE 1.5MM DRILL BIT SPLIT. IT'S PARTS WERE RECOVERED. THERE WAS NO SURGICAL DELAY REPORTED. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH FOR 03.503.045/.047. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11399228 ↗
• InjuryFeb 19, 2021Overheating of Device; Overheating of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING A BIMAXILLARY OSTEOTOMY PROCEDURE, THE CUSTOMER REPORTED THE MATRIXMANDIBLE 1.5MM DRILL BIT HEATED UP IN THE TRANSBUCCAL CANNULA AND THE UNIVERSAL TROCAR HANDLE. THE HEAT CAUSED THE DRILL BIT TO BLACKEN AT THE TIME. THE SURGEON BELIEVED THE HEAD BURNED THE BONE AND THE CHEEK SOFT TISSUE. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THE PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: DRILLSL LONG F/MATMAND (PART NUMBER 03.503.045, LOT UNKNOWN, QUANTITY 1). UNIV-HANDLE F/DRILLSLEEVES (PART NUMBER 397.211, LOT UNKNOWN, QUANTITY 1). TRUMATCH ORTHOGNATHIC KIT FULL BIMAXILLARY (PART NUMBER SD980.001, LOT ME20MEHKEB, QUANTITY 1). MATRIXMANDIBLE DRILL BIT Ø1.5 2FLUTE F/0 (PART NUMBER 03.503.476, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH FOR 03.503.045/.047. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Burn(s)

  MAUDE report 11349899 ↗
• InjuryFeb 18, 2021Overheating of Device; Overheating of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING A BIMAXILLARY OSTEOTOMY PROCEDURE, THE CUSTOMER REPORTED THE MATRIXMANDIBLE 1.5MM DRILL BIT HEATED UP IN THE TRANSBUCCAL CANNULA AND THE UNIVERSAL TROCAR HANDLE. THE HEAT CAUSED THE DRILL BIT TO BLACKEN AT THE TIME. THE SURGEON BELIEVED THE HEAD BURNED THE BONE AND THE CHEEK SOFT TISSUE. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH FOR 03.503.045/.047. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Burn(s)

  MAUDE report 11345926 ↗
• InjuryApr 22, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING SURGERY THE MATRIX MANDIBLE DRILL BIT PIECE BROKE OFF IN THE PATIENT'S MANDIBLE. ATTEMPTS TO REMOVE THE PIECE WERE UNSUCCESSFUL. THE DECISION WAS MADE TO LEAVE THE PIECE IN PLACE. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 9987410 ↗
• InjuryApr 10, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING A MANDIBLE RECONSTRUCTION AND FIBULA FLAP PROCEDURE, THE MATRIX MANDIBLE DRILL BIT WAS BROKEN. WHEN THE SURGEON WAS DRILLING INTO THE MANDIBLE AND TORQUED THEIR HAND WHILE RUNNING THE DRILL BIT, THE DRILL BIT SNAPPED OFF AND WHEN THE SURGEON WENT BACK TO PICK IT UP, IT BROKE AGAIN. THE SURGEON TRIED TO REMOVE THE DRILL BIT PIECE BUT WAS NOT ABLE, SO THE SURGEON DECIDED TO LEAVE IT IN THE PATIENT. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN DRILL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) MATRIX MANDIBLE 1.5MM DRILL BIT J-LATCH FOR 03.503.045/.047. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 9948460 ↗
• MalfunctionOct 28, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE DRILL BIT WAS BROKEN DURING AN UNKNOWN PROCEDURE. IT IS UNKNOWN IF THERE WERE FRAGMENTS GENERATED. THERE WAS NO SURGICAL DELAY REPORTED. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH FOR 03.503.045/.047. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9246466 ↗
• MalfunctionDec 28, 2018Overheating of Device; Overheating of Device

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, DURING THE INTER-MOLAR DISTRACTION OSTEOGENESIS (IMDO) PROCEDURE, TWO (2) TRUMATCH MANDIBLE GUIDE WERE HEATING UP DURING PRE-DRILLING. THE CYLINDER AND GUIDES WERE HEATING UP DUE TO THE DRILL. IT WAS NOTED THREE (3) DRILL BITS WERE TOUCHING THE CYLINDER BECAUSE OF THE ANGULATION OF THE GUIDE. THERE WAS NO SURGICAL DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT AND THERE WAS NO ISSUE WITH THE PLATES OR SCREWS. CONCOMITANT DEVICES REPORTED: MANDIBLE PLATE (PART/LOT UNKNOWN, QUANTITY UNKNOWN), MANDIBLE SCREW (PART/LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR A DRILL BIT. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8202849 ↗
• MalfunctionDec 27, 2018Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A MATRIXMANDIBLE DRILL BIT BROKE. THERE IS NO PROCEDURE OR PATIENT INVOLVEMENT. THIS REPORT IS FOR A MATRIXMANDIBLE 1.5MM DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8199386 ↗
• MalfunctionAug 1, 2018Break; Break

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, THE MATRIXMANDIBLE DRILL BIT FROM A MATRIX COMBO SET SNAPPED WHILE THE SURGEON WAS LOADING IT INTO A PNEUMATIC DRILL. THE SURGEON SPUN THE DRILL BIT WITHOUT A GUARD ON IT, CAUSING IT TO SPIN SO HARD THAT IT SNAPPED. THE DRILL BIT LANDED ON THE FLOOR AND IT WAS ACTUATED OUTSIDE THE PATIENT SO THERE WAS NO PATIENT INTERACTION. THE SURGEON USED A SECOND DRILL BIT AND DRILL GUIDE THROUGHOUT THE CASE. NO PATIENT OUTCOME REPORTED. THERE WAS NO PATIENT CONSEQUENCE AND SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: PNEUMATIC DRILL (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: No Consequences Or Impact To Patient

  MAUDE report 7740522 ↗
• MalfunctionJul 24, 2018Break; Break

  IT WAS REPORTED THAT DURING A MANDIBLE OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE ON (B)(6) 2018, A MATRTIXMANDIBLE DRILL BIT FOR J-LATCH COUPLING BROKE WHILE DRILLING. THE TWO (2) SEGMENTS GENERATED FROM THE BROKEN DEVICE WERE SUCCESSFULLY RETRIEVED WITHOUT CAUSING HARM TO THE PATIENT. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE PATIENT IN STABLE CONDITION. THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE 1.5MM DRILL BIT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7715716 ↗
• InjuryJul 24, 2018Overheating of Device; Overheating of Device

  IT WAS REPORTED PATIENT UNDERWENT AN UNKNOWN ORAL PROCEDURE ON (B)(6) 2018. DURING THE PROCEDURE, THE SURGEON USED THE MATRIXMANDIBLE 1.5MM DRILL BIT INTRA-ORALLY THROUGH A 2.0MM CANNULA. THE MOUTH AREA WAS IRRIGATED BUT THE CANNULA WAS NOT. THE DRILL SPEED WAS REPORTED AS 28,000 RPM. SURGEON STATED THE DRILL BIT BECAME VERY HOT AND SUSPECTS THE FIT BETWEEN THE DRILL BIT AND CANNULA MAY BE TOO TIGHT, WHICH MAY HAVE CAUSED FRICTION AND HEAT. WHILE IT WAS INITIALLY REPORTED THAT PATIENT WAS NOT INJURED, SURGEON LATER REPORTED THE PATIENT¿S SKIN SURROUNDING THE DRILL AND TROCAR WAS HYPERTROPHIC (BURNED) ASSOCIATED WITH THIS EVENT. SURGEON STATED PATIENT MAY REQUIRE PLASTIC SURGERY CONSULTS AND/OR TREATMENT OF THE HYPERTROPHIC AREA. CONCOMITANT DEVICES REPORTED: 2.0MM CANNULA & OBTURATOR (397.213, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE 1.5MM DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Burn(s)

  MAUDE report 7714614 ↗
• InjuryJul 17, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SURGEON WAS DRILLING A HOLE TO IMPLANT A SCREW AND THE DRILL BIT BROKE OFF IN THE PATIENT. AN ADDITIONAL INCISION HAD TO BE MADE TO RETRIEVE THE BROKEN DRILL BIT FRAGMENT. THE ENTIRE DRILL BIT WAS REMOVED SUCCESSFULLY. THERE WAS NO HARM TO THE PATIENT BEYOND TO THE ADDITIONAL INCISION. THERE WAS A SURGICAL DELAY OF AN UNKNOWN LENGTH DUE TO THE REPORTED EVENT, BUT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Laceration(s)

  MAUDE report 7695132 ↗

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