NA 310.141SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982185990), received between Nov 7, 2017 and Jan 29, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2024Break; Use of Device Problem; Break; Use of Device Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, TWO DRILL BITS SPLIT DURING SURGERY. THERE WAS NO EFFECT TO THE PATIENT. THIS REPORT INVOLVES ONE 1.5MM DRILL BIT/MINI QC/65MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18596735 ↗
• MalfunctionApr 12, 2022Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, A DRILL BIT BROKE WHILE THE SURGEON WAS DRILLING THE BONE. ANOTHER DRILL BIT WAS USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A 1.5MM DRILL BIT/MINI QC/65MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14085096 ↗
• MalfunctionNov 7, 2017Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE DISTRIBUTOR NOTED TWO (2) BROKEN DRILL BITS. ONE (1) HAS A BROKEN TIP, THE OTHER IS BROKEN INTO THREE (3) PIECES. NO PATIENT INVOLVEMENT WAS REPORTED. THIS REPORT IS FOR ONE (1) 1.5 MM DRILL BIT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7007665 ↗