NA 313.925Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587037028), received between Apr 27, 2018 and Sep 7, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 7, 2023Break; Crack; Break; Crack

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREWDRIVER WAS CHIPPED/CRACKED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 2.4MM SCREWDRIVER SELF-RETAINING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17698239 ↗
• InjuryApr 27, 2018Break; Break

  IT WAS REPORTED THAT THE TIP OF A SCREWDRIVER BROKE WHILE PLACING A SCREW IN THE PATIENT¿S MANDIBLE DURING A PROCEDURE ON (B)(6) 2018. THE WOUND WAS EXAMINED AND A PIECE OF THE DRIVER WAS RECOVERED. IT IS UNKNOWN IF ALL THE PIECES OF THE DRIVER WERE REMOVED. THE WOUND WAS COPIOUSLY IRRIGATED AND SUCTIONED. THIS BREAKAGE ADDED 15 MINUTES TO THE CASE. NO PATIENT CONSEQUENCE REPORTED. NO OTHER ADDITIONAL INFORMATION AVAILABLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7468562 ↗