NA 388.394Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10705034772745), received between Jul 6, 2017 and Jul 11, 2024 — classified as 5 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Break” (14 reports).

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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT SPINAL FUSION ON (B)(6) 2024. THE SURGEON WAS USING THE 2.4 DIAMETER SYNAPSE DRILL, AND IT BROKE INSIDE THE PATIENT'S PEDICLE. IT WAS REMOVED WITH NO PROBLEM AND NO HARM WAS DONE TO THE PATIENT. ANOTHER 2.4 DIAMETER DRILL WAS USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR A 2.4MM DRILL BIT/QC WITH 65MM STOP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19725248 ↗
• MalfunctionDec 1, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON OCTOBER 30, 2023, A REMOVAL SURGERY WAS PERFORMED AT C7. IN THE SURGERY, OSTEOSCLEROSIS WAS OBSERVED WHEN REMOVING THE SCREW, AND THE DRILL BIT IN QUESTION WAS USED ALONG WITH A CHISEL. AT THE TIME, THE BONE WAS SO HARD THAT THE TIP BROKE. THE BROKEN TIP WAS REMOVED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THE PATIENT STATUS WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE 2.4MM DRILL BIT/QC WITH 65MM STOP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18248702 ↗
• MalfunctionOct 24, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING A SPINE SURGERY ON (B)(6) 2023, ONE OF THE 2.4MM DRILL BITS LOST ITS YELLOW COLOR COATING WHILE THE SURGEON WAS DRILLING FOR SCREW INSERTION. THE YELLOW PAINT COATING FELL OFF THE DRILL BIT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO PATIENT COMPLICATIONS WERE REPORTED. THIS REPORT INVOLVES ONE 2.4MM DRILL BIT/QC WITH 65MM STOP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17995815 ↗
• MalfunctionOct 4, 2023Material Integrity Problem; Material Integrity Problem

  THE INCIDENT HAD NO IMPACT ON THE PATIENT, DID NOT LEAD TO SURGICAL DELAY OR CAUSED CHANGES IN THE SURGICAL METHOD.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17868413 ↗
• MalfunctionJun 5, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A DRILL BIT WAS RECEIVED AS A BLIND UNIT IN LOCAL STOCK MARKED WITH RED TAPE. UPON MANUFACTURER INVESTIGATION, IT WAS DETERMINED THAT THE DEVICE WAS BROKEN FROM THE TIP. THIS REPORT IS FOR A 2.4MM DRILL BIT/QC WITH 65MM STOP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17059184 ↗
• MalfunctionApr 24, 2023No Apparent Adverse Event; No Apparent Adverse Event

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE DEVICE IN QUESTION WAS RECEIVED AS A BLIND UNIT FROM COLOMBIA. THERE IS NO ALLEGATION REPORTED AGAINST THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.4MM DRILL BIT/QC WITH 65MM STOP. THIS IS REPORT 1 OF 1 FOR (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16794596 ↗
• MalfunctionApr 7, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE DEVICE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DRILL BIT Ø2.4 W/STOP 2FLUTE F/QC THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16702289 ↗
• MalfunctionAug 16, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A CERVICAL ARTHRODESIS, WITH THE SYNAPSE SYSTEM, THE TIPS OF THE DRILL BITS RUPTURED. THERE WERE NO REPORTED PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) DRILL BIT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15232436 ↗
• MalfunctionAug 16, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A CERVICAL ARTHRODESIS, WITH THE SYNAPSE SYSTEM, THE TIPS OF THE DRILL BITS RUPTURED. THERE WERE NO REPORTED PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) DRILL BIT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15232405 ↗
• MalfunctionOct 22, 2021Material Integrity Problem; Material Integrity Problem

  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 TO TREAT CERVICAL DAMAGE. DURING THE SURGERY, WHILE THE SURGEON WAS ADJUSTING SCREW INSERTION DIRECTION AGAINST THE HARDENED BONE, THE DRILL BIT TIP¿S BREAKAGE. THE FRAGMENTED TIP WAS REMOVED FROM THE PATIENT¿S BODY. ALSO, THE TORQUE LIMITATION HANDLE BECAME OUT OF ORDER DURING ROD DEPLOYMENT. THE PROCEDURE WAS COMPLETED LESS THAN 30-MINUTE SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW -SPINE: (PART# UNKNOWN; LOT# UNKNOWN; QUALITY:1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) 2.4MM DRILL BIT/QC WITH 65MM STOP. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12681869 ↗
• MalfunctionJun 7, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6), 2021, WHEN DRILLING THE LATERAL MASS, THE DILL BIT BROKE INTO TWO PIECES. A PIECE WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT. AN X-RAY WAS TAKEN TO CHECK ALL METAL FRAGMENTS HAD BEEN REMOVED FROM THE PATIENT. NO IMMEDIATE PATIENT HARM. THIS REPORT IS FOR ONE (1) 2.4MM DRILL BIT/QC WITH 65MM STOP. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11952253 ↗
• MalfunctionFeb 15, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2021 THAT THE PATIENT UNDERWENT FOR A POSTERIOR CERVICAL FIXATION SURGERY. DURING THE SURGERY, WHEN THE DRILL HAD BEEN USED THROUGH THE DRILL GUIDE IT WAS MOVED LATERALLY BEFORE BEING REMOVED OUT OF THE SHAFT, THEREFORE SNAPPING THE DRILL BIT. THIS CAME OUT OF THE GUIDE WITHOUT ISSUES. THERE WAS NO PATIENT IMPACT OR DELAY TO SURGERY. CONCOMITANT DEVICE REPORTED: UNKNOWN DRILL GUIDE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 2.4MM DRILL BIT/QC WITH 65MM STOP. THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11330285 ↗
• InjuryOct 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING A POSTERIOR SPINAL FUSION, TWO SCREWS WERE DEPLOYED AT C2. AND THE SURGEON MOVED ON TO MAKING A SCREW HOLE AT C1. THE PATIENT SUFFERED FROM A LARGE HEMORRHAGE DURING THE DRILLING. THE SURGEON DEPLOYED THE SCREW AT C1 WHILE CONDUCTING HEMOSTASIS SIMULTANEOUSLY. THE ANESTHESIOLOGIST ADVISED THE SURGEON TO STOP THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART # UNKNOWN, LOT # UNKNOWN, QTY 3). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 2.4MM DRILL BIT/QC WITH 65MM STOP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10750852 ↗
• MalfunctionAug 27, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE DISTAL END OF THE DRILL BROKE OFF INTRAOPERATIVELY DURING A POSTERIOR CERVICAL ARTHRODESIS PROCEDURE ON AN UNKNOWN DATE. THE FRAGMENT WAS RETRIEVED AND THE PROCEDURE SUCCESSFULLY COMPLETED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10459113 ↗
• InjuryJul 20, 2020Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2020, THE SYNAPSE DRILL BIT BROKE AND WAS INSERTED INTO THE PATIENT'S CERVICAL SPINE. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR A 2.4MM DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 10295042 ↗
• MalfunctionJun 26, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING THE CERVICAL ARTHRODESIS PROCEDURE, IN THE PREPARATION PHASE OF THE PEDICLE SCREW PLACEMENT, THE DISTAL PORTION OF THE TWO (2) DRILL BITS BROKE. THE FRAGMENTS WERE RECOVERED EASILY. PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY ADVERSE EVENT. PATIENT OUTCOME IS REPORTED AS GOOD. CONCOMITANT DEVICE REPORTED: SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 2.4MM DRILL BIT. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10201635 ↗
• MalfunctionJun 26, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING THE CERVICAL ARTHRODESIS PROCEDURE, IN THE PREPARATION PHASE OF THE PEDICLE SCREW PLACEMENT, THE DISTAL PORTION OF THE TWO (2) DRILL BITS BROKE. THE FRAGMENTS WERE RECOVERED EASILY. PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY ADVERSE EVENT. PATIENT OUTCOME IS REPORTED AS GOOD. CONCOMITANT DEVICE REPORTED: SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN) THIS REPORT IS FOR ONE (1) 2.4MM DRILL BIT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10201632 ↗
• MalfunctionJun 17, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A SPINAL FUSION IN OC7 TREATING CERVICAL ANOMALY ON (B)(6) 2020, THE DRILL¿S TIP CHIPPED DURING USE. A FRAGMENT WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. PATIENT WAS STABLE. THIS REPORT IS FOR A 2.4MM DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10164149 ↗
• MalfunctionJan 14, 2020Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE DRILL FOUND WAS SNAPPED AND SHORTER DURING THE SURGERY. THE SNAPPED PORTION OF THE DRILL WAS NOT LEFT IN THE WHOLE THEY HAD BEEN DRILLING. IT WAS LOOSE IN THE WOUND AND EASILY RETRIEVED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9586327 ↗
• InjuryNov 11, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2019, THE SYNAPSE 2.4 MM DRILL HAS BROKEN INSIDE THE PATIENT C2 CERVICAL PEDICLE. THE FRAGMENT WAS EXTRACTED BY DR (B)(6) WITH A PAIR OF MINI FORCEPS WITH NO CONSEQUENCE TO THE PATIENT. THE SURGERY WAS DELAYED BY 60 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Code Available

  MAUDE report 9306504 ↗
• MalfunctionAug 14, 2019Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A NEUROSURGERY PROCEDURE ON (B)(6) 2019, THE DRILL BIT BROKE WHEN THE MASSA LATERALIS (C5) WAS PERFORATED. SURGERY COMPLETED USING AWL. NO HARM TO PATIENT; MINIMAL DELAY IN SURGERY. THIS REPORT IS FOR A 2.4 MM DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8892806 ↗
• InjuryJul 17, 2019Break; Break

  THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8800178 ↗
• MalfunctionJun 6, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, A CERVICAL POSTERIOR FIXATION SURGERY AT C4 WAS PERFORMED. DURING THE SURGERY, WHEN THE SURGEON TRIED TO DRILL FOR THE PILOT HOLE FOR AN UNKNOWN LATERAL MASS SCREW BY SIZING UP TO 16 OR 18MM, THE DRILL BIT BROKE OFF. THEN, THE SURGEON USED AN ALTERNATIVE DRILL BIT TO CONTINUE DRILLING, HOWEVER, THE DRILL BIT WAS ALSO BROKEN. THUS, THE SURGERY WAS COMPLETED BY USING ANOTHER ALTERNATIVE DRILL BIT. ALL BROKEN FRAGMENTS WERE REMOVED. THERE WAS A 5-MINUTE SURGICAL DELAY AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICES REPORTED: UNKNOWN HANDLE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY OF 1). THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8675981 ↗
• MalfunctionJun 6, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, A CERVICAL POSTERIOR FIXATION SURGERY AT C4 WAS PERFORMED. DURING THE SURGERY, WHEN THE SURGEON TRIED TO DRILL FOR THE PILOT HOLE FOR AN UNKNOWN LATERAL MASS SCREW BY SIZING UP TO 16 OR 18MM, THE DRILL BIT BROKE OFF. THEN, THE SURGEON USED AN ALTERNATIVE DRILL BIT TO CONTINUE DRILLING, HOWEVER, THE DRILL BIT WAS ALSO BROKEN. THUS, THE SURGERY WAS COMPLETED BY USING ANOTHER ALTERNATIVE DRILL BIT. ALL BROKEN FRAGMENTS WERE REMOVED. THERE WAS A 5-MINUTE SURGICAL DELAY AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICES REPORTED: UNKNOWN HANDLE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY OF 1). THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8675933 ↗
• MalfunctionJan 23, 2019Break; Break

  FURTHER IT WAS REPORTED THAT THE BROKEN DRILL BIT WAS RETRIEVED EASILY. SURGEON USED ANOTHER DRILL BIT TO COMPLETE THE PROCEDURE. THERE WAS SURGICAL DELAY OF COUPLE OF MINUTES. SURGERY CONTINUED WITHOUT FURTHER INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8272344 ↗