NA 395.330Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705034777405), received between Nov 9, 2018 and Aug 6, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (4 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.

• MalfunctionAug 6, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A SPINAL FUSION SURGERY ON (B)(6) 2024, THE SURGEON BROKE THE HANDLE ON THE ANGULATES ODONTOID SCREWDRIVER. IT WAS SUSPECTED THAT THE RESIN-LIKE HANDLE WAS LIKELY DRIED OUT AND THAT IS HOW IT DETACHED FROM THE DRIVER. THE CASE WAS COMPLETED WITH THE SAME DRIVER. THE PATIENT WAS NOT IMPACTED; FRAGMENTS WERE REMOVED EASILY WITHOUT REQUIRING ADDITIONAL INTERVENTION. THE PROCEDURE WAS NOT DELAYED. THIS REPORT INVOLVES ONE ANGLED CANNULATED SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19917730 ↗
• MalfunctionOct 13, 2021Material Integrity Problem; Material Integrity Problem

  THE SCREWDRIVER WAS NOT INTACT. THERE WAS AN UNKNOWN AMOUNT OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12627953 ↗
• MalfunctionAug 16, 2021Material 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 IN 2021, THE ANGLED CANNULATED SCREWDRIVER WAS FOUND TO BE BROKEN. THE ISSUE WAS DISCOVERED PRE-OPERATIVELY. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR (1) ANGLED CANNULATED SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12325397 ↗
• MalfunctionApr 26, 2021Material 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 CLEANING PROCESS IT WAS NOTICED THAT THE INSTRUMENT IS DEFECTIVE. A PART OF THE DRIVE AT THE ANGLED PART HAS BROKEN OFF. THERE WAS NO SURGERY AND PATIENT INVOLVEMENT REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) ANGLED CANNULATED SCREWDRIVER. THIS REPORT IS 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11724109 ↗
• MalfunctionSep 22, 2020Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE BOLT CAME LOOSE AND THE INSTRUMENT FALLS APART. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) ANGLED CANNULATED SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10568127 ↗
• MalfunctionAug 6, 2020Break; Break

  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 ANGLED CANNULATED SCREWDRIVER WAS FOUND TO BE DAMAGED. THERE WAS NO PATIENT CONSEQUENCES. THE PROCEDURE WAS COMPLETED WITH THE USE OF ANOTHER PRODUCT OF THE SAME TYPE. THIS REPORT IS FOR ONE (1) ANGLED CANNULATED SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10373093 ↗
• MalfunctionNov 9, 2018Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SMALL SCREW THAT CONNECTS THE ANGLED CANNULATED SCREWDRIVER HANDLE TO THE BRIDGE OF THE ODONTOID SCREW, BROKE DURING AN UNKNOWN PROCEDURE. THE SURGEON USED THE SIMPLE HANDLE TO COMPLETE THE PROCEDURE. THERE WAS A SLIGHT DELAY IN THE PROCEDURE. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) ANGLED CANNULATED SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR PC-(B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8055301 ↗