NA 03.617.914Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705034717227), received between Jun 14, 2019 and Mar 6, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING THE DRILLING PROCESS, THE DRILL BIT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24532123 ↗
• MalfunctionDec 30, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT AT THE MOMENT OF PASSING THE AWL AND THE DRILL BIT, THE FIRST PIECE BROKE AND THE SECOND TWISTED. THERE WAS NO PATIENT HARM. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21036890 ↗
• MalfunctionOct 16, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT WHEN DRILLING THE SCREW HOLES THROUGH THE AIMING DEVICE FOR ZERO-P, THE 14MM DRILL BIT BROKE. FRAGMENTS WERE GENERATED. THE BROKEN DRILL BIT WAS REMOVED FROM THE SURGICAL FIELD. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20466447 ↗
• MalfunctionMay 16, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED, DURING ANTERIOR CERVICAL ARTHRODESIS SURGERY WITH THE ZERO P SYSTEM, DURING DRILLING WITH THE DRILL BIT THROUGH THE IMPLANT POSITIONER, IT WAS BROKEN. THE FRAGMENT WAS RECOVERED AND THE PROCEDURE CONTINUED WITHOUT AFFECTING THE PATIENT. THIS REPORT IS FOR ONE DRILL BIT Ø2 DRILLDEPTH14 3FLUTE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14411308 ↗
• MalfunctionNov 27, 2020Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING AN UNKNOWN PROCEDURE, THE TIP OF THE 2.0MM DRILL BIT BROKE OFF DURING USE. THERE WAS A SURGICAL DELAY OF 15 MINUTES. FRAGMENTS WERE GENERATED AND EASILY REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER DRILL BIT. THIS REPORT IS FOR 1 2.0MM DRILL BIT WITH 14MM STOP QC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10915079 ↗
• MalfunctionJun 10, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6). AS FOLLOWS: IT WAS REPORTED THE TIP OF DRILL BROKE OFF INTRAOPERATIVELY DURING AN UNKNOWN PROCEDURE. NO SURGERY DELAY OR ADVERSE PATIENT AFFECT REPORTED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10138831 ↗
• MalfunctionJun 14, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PERU AS FOLLOWS: IT WAS REPORTED THAT ON (B)(4) 2019, A DRILL BIT WAS BROKEN DURING AN UNKNOWN PROCEDURE. THE TIP OF THE DRILL BIT GOT IN THE CERVICAL VERTEBRAL BODY OF THE PATIENT, HOWEVER IT COULD BE EXTRACTED WITH A HEMOSTATIC CLAMP AT THE TIME WITHOUT CAUSING MAJOR PROBLEM. THERE WERE NO FRAGMENTS LEFT IN THE PATIENT. THERE WAS ANOTHER DRILL BIT WAS USED TO COMPLETE THE PROCEDURE. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY REPORTED. PATIENT OUTCOME WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8701683 ↗