NA 310.11Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982185907), received between Feb 24, 2022 and Dec 4, 2025 — classified as 2 injuries, 3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE DRILL BIT BROKE WHILE BEING USED TO DRILL. A FRAGMENT OF THE DRILL BIT REMAINED INSIDE THE BONE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23714817 ↗
• MalfunctionApr 14, 2023No Apparent Adverse Event; No Apparent Adverse Event

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED, THAT THE DEVICE WAS RECEIVED AS A BLIND UNIT FROM COLOMBIA ON JANUARY 19, 2023. THERE WAS NO ALLEGATION REPORTED AGAINST THE DEVICE. UPON PRODUCT INVESTIGATION COMPLETED ON APRIL 13, 2023, IT WAS NOTED THAT THE DEVICE WAS BROKEN FROM THE DISTAL TIP. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 1.1MM DRILL BIT/QC/60MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16743379 ↗
• MalfunctionAug 10, 2022Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE DRILL BIT IN QUESTION WAS FOUND TO BE BROKEN. THERE IS NO REPORTED PATIENT INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.1MM DRILL BIT/QC/60MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15200772 ↗
• InjuryFeb 24, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, THE DRILL BIT BROKE OFF IN THE PATIENT, AND WAS PERMANENTLY LEFT IN THE PATIENT. IT OCCURRED TWICE AND THERE ARE TWO FRAGMENTS LEFT IN THE PATIENT. THIS CAUSED A SURGICAL DELAY OF 30 MINUTES. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) 1.1MM DRILL BIT/QC/60MM THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 13593955 ↗
• InjuryFeb 24, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, THE DRILL BIT BROKE OFF IN THE PATIENT, AND WAS PERMANENTLY LEFT IN THE PATIENT. IT OCCURRED TWICE AND THERE ARE TWO FRAGMENTS LEFT IN THE PATIENT. THIS CAUSED A SURGICAL DELAY OF 30 MINUTES. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR (1) 1.1MM DRILL BIT/QC/60MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 13590526 ↗