NA 317.82Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10887587038773), received between Jun 25, 2018 and Apr 15, 2021 — classified as 8 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2021Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, WHEN THE SURGEON PIERCED THE PATIENT'S BONE, THE DRILL BROKE, LEAVING THE TIP INSIDE THE PATIENT'S BONE. THIS REPORT INVOLVES ONE (1) 1.5MM DRILL BIT/MINI QC WITH 12MM STOP/44.5MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11671308 ↗
• InjuryApr 13, 2021Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, WHEN DRILLING THE PATIENT BONE, THE DRILL BIT BREAK OFF AND LEAVING THE DRILL TIP INSIDE THE PATIENT¿S BONE. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 1.5 DRILL BIT/MINI QC WITH 12 STOP/44.5 THIS REPORT IS 1 OF 1 (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11659347 ↗
• MalfunctionMar 30, 2021Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, THE DRILL BIT BROKE. THIS REPORT IS FOR A 1.5MM DRILL BIT/MINI QC WITH 12MM STOP/44.5MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11589441 ↗
• MalfunctionMar 22, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY FOR LOWER JAW FRACTURE. DURING THE SURGERY, WHILE DRILLING THE BONE THE DRILL GETS SPLIT. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) IMPLANT INSERTER SH CONNECTION. THIS REPORT IS 1 OF 3 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11546130 ↗
• MalfunctionFeb 8, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE PROCEDURE THE DRILL BIT TIP WAS BREAK-OFF. THERE WAS ANOTHER DRILL BIT USED AND SAME THING OCCURRED. IT WAS UNKNOWN IF THE PROCEDURE SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 1.5MM DRILL BIT/MINI QC WITH 12MM STOP/44.5MM. THIS IS REPORT 2 OF 2 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11297809 ↗
• MalfunctionFeb 2, 2021Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON DECEMBER 30, 2020, THE 1.5X12MM DRILL BROKE. THIS REPORT IS FOR A 1.5MM DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11266700 ↗
• InjuryJan 19, 2021Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THAT WHILE DRILLING THE HOLE WITH A 1.5MM DRILL BIT USING THE 12MM STOP, THE DRILL BIT FRACTURED AND REMAINED WITHIN THE HOLE BETWEEN THE JAW BONE AND THE PROSTHESIS TO BE IMPLANTED. THE DRILL FRAGMENT WAS REMOVED. THIS REPORT IS FOR ONE (1) 1.5MM DRILL BIT/MINI QC WITH 12MM STOP/44.5MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11195860 ↗
• MalfunctionJan 7, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING DRILLING FOR A MANDIBULAR OSTEOSYNTHESIS PROCEDURE, THE 1.5MM DRILL BROKE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 1.5MM DRILL BIT/MINI QC WITH 12MM STOP/44.5MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11136359 ↗
• InjuryDec 28, 2020Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING A PROCEDURE, THAT THE DRILL BIT BROKE AND ONE OF THE FRAGMENTS BECAME EMBEDDED IN THE PATIENT'S BONE. THE FRAGMENT WAS LEFT IN THE PATIENT'S BONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORTED CONSEQUENCE TO THE PATIENT. THIS REPORT INVOLVES ONE (1) 1.5MM DRILL BIT/MINI QC WITH 12MM STOP/44.5MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11076800 ↗
• InjuryNov 23, 2020Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING AN OPEN REDUCTION PROCEDURE AND OSTEOSYNTHESIS OF MANDIBLE FRACTURE, THE 1.5MM DRILL BIT REMAINED INSIDE THE PATIENT'S BONE. THE SURGEON DECIDED NOT TO REMOVE IT BECAUSE THE FRAGMENT WAS VERY SMALL AND THEY DID NOT WANT TO INJURE THE BONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 1.5MM DRILL BIT/MINI QC WITH 12MM STOP/44.5MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 10886645 ↗
• MalfunctionNov 6, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT FOR BONE (BONE DRILLING) PIERCING SURGERY. DURING THE SURGERY, THE DRILL WAS BROKEN OFF. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO HARM TO THE PATIENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) 1.5MM DRILL BIT/MINI QC WITH 12MM TOP/44.5MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10803565 ↗
• InjuryNov 2, 2020Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, WHILE PLACING THE SECOND SCREW, THE SURGEON ASKED FOR A 12MM LONG DRILL BIT OF 1.5MM. DURING DRILLING IN THE JAWBONE, THE TIP OF THE DRILL BIT BROKE AND REMAINED INSIDE THE PATIENT BONE. SURGEON DECIDED TO LEAVE IT THERE, AS IT WAS DIFFICULT TO REMOVE THE FRAGMENT OF THE DRILL BIT. SURGEON PLACED THE LESSER LENGTH SCREW IN THAT HOLE. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION PROVIDED. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) 1.5MM DRILL BIT/MINI QC WITH 12MM STOP/44.5MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 10771384 ↗
• InjuryJun 17, 2020Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING MAXILLOFACIAL SURGERY FOR FACIAL TRAUMA (MANDIBLE), WHILE DRILLING FOR SHARPS TO INSERT SCREWS, THE TWO (2) DRILL BITS BROKE WITHOUT THE POSSIBILITY OF RECOVERING THE FRAGMENTS. THERE WAS SURGICAL DELAY OF TWENTY (20) MINUTES. SURGERY WAS COMPLETED BY CHANGING THE DRILL BITS. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION PROVIDED. CONCOMITANT DEVICE REPORTED: SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) 1.5MM DRILL BIT/MINI QC WITH 12MM STOP/44.5MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 10165440 ↗
• InjuryJun 8, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING FACIAL TRAUMA MAXILLOFACIAL SURGERY THAT TWO DRILL BITS BROKE. FRAGMENTS WERE GENERATED. FRAGMENTS OF ONE DRILL BIT WERE RECOVERED. FRAGMENTS FROM THE SECOND DRILL BIT WERE NOT SUCCESSFULLY RECOVERED. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE IS NO KNOWN PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) 1.5MM DRILL BIT/MINI QC WITH 12MM STOP/44.5 MM. THIS IS REPORT 2 OF 2 FOR PC-(B)(4).

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 10127502 ↗
• MalfunctionJun 25, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, TWO (2) DRILL BITS BROKE DURING A MANDIBULAR OSTEOSYNTHESIS PROCEDURE. ONE OF THE FRAGMENTS WAS RECOVERED BY HAND, THE OTHER FRAGMENT WAS REMOVED WITH SUCTION. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR A 1.5MM DRILL BIT/MINI QC WITH 12MM STOP/44.5MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7634909 ↗
• MalfunctionJun 25, 2018Break; Break

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, TWO (2) DRILL BITS BROKE DURING A MANDIBULAR OSTEOSYNTHESIS PROCEDURE. ONE OF THE FRAGMENTS WAS RECOVERED BY HAND, THE OTHER FRAGMENT WAS REMOVED WITH SUCTION. IT WAS UNKNOWN IF THERE WERE SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR A 1.5MM DRILL BIT/MINI QC WITH 12MM STOP/44.5MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7634881 ↗

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