NA 03.505.205Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587013909), received between Oct 23, 2019 and Jun 10, 2022 — 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 18, 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.

• MalfunctionJun 10, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON REPORTED THAT WHEN USING THE KIT PREVIOUSLY ONE OF THE SCREWDRIVERS SNAPPED. THIS REPORT INVOLVES ONE (1) CRUCIFORM SCREWDRIVER BLADE HEX COUPLING/SMALL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14655525 ↗
• InjuryOct 23, 2019Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED AN IMPLANT REMOVAL PROCEDURE FOR THE MIDFACE OCCURRED ON (B)(6)J 2019 FOR AN UNKNOWN REASON. THE PROCEDURE WAS TO REMOVE NINE (9) SCREWS. THE SCREWDRIVER DID NOT PROPERLY ENGAGE WITH MULTIPLE SCREWS. TWO SCREWS WERE REMOVED WITH THE SCREWDRIVER. HOWEVER, THERE WAS CONTINUED DIFFICULTY AND THE SURGEON NEEDED TO REMOVE SEVEN (7) SCREWS OUT OF THE NINE BY GRINDING THOSE SCREWS WITH A DRILL. THE PROCEDURE WAS DELAYED BY 70 MINUTES. CONCOMITANT DEVICE REPORTED: UNKNOWN POWERED DRIVERS/HANDPIECES: TRAUMA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 2) . THIS IS REPORT 1 OF 8 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9224966 ↗