NA 315.330Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982189295), received between Jul 28, 2017 and Feb 28, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 28, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING INSPECTION OF THE DEVICES, IT WAS NOTED THE 3.2MM THREE-FLUTED DRILL BIT IS BROKEN. NO PATIENT INVOLVEMENT WAS REPORTED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7304955 ↗
• MalfunctionJul 28, 2017Break; Device Operates Differently Than Expected; Break; Device Operates Differently Than Expected

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT PARTS WERE DETECTED AS DAMAGED DURING INTERNAL INSPECTION OF LOANER KITS. REPORTEDLY THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR A DRILL BIT WHICH REPORTEDLY WAS DAMAGED. WHEN THE DEVICE WAS RECEIVED, IT WAS NOTED THAT THE DISTAL TIP WAS BROKEN; THE BROKEN PORTION WAS NOT RECEIVED. THIS REPORT IS FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6751886 ↗
• MalfunctionJul 28, 2017Break; Device Operates Differently Than Expected; Break; Device Operates Differently Than Expected

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT PARTS WERE DETECTED AS DAMAGED DURING INTERNAL INSPECTION OF LOANER KITS. REPORTEDLY THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR A DRILL BIT WHICH REPORTEDLY WAS DAMAGED. WHEN THE DEVICE WAS RECEIVED, IT WAS NOTED THAT THE DISTAL TIP WAS BROKEN; THE BROKEN PORTION WAS NOT RECEIVED. THIS REPORT IS FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6751752 ↗
• MalfunctionJul 28, 2017Break; Device Operates Differently Than Expected; Break; Device Operates Differently Than Expected

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT PARTS WERE DETECTED AS DAMAGED DURING INTERNAL INSPECTION OF LOANER KITS. REPORTEDLY THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR DRILL BIT WHICH REPORTEDLY DID NOT FIT WITH OTHER PARTS. WHEN THE DEVICE WAS RECEIVED, IT WAS NOTED THAT THE PROXIMAL COUPLING POST WAS BROKEN; THE BROKEN PORTION WAS NOT RECEIVED. THIS REPORT IS FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6750076 ↗