NA 03.120.041Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982074294), received between Jun 21, 2018 and Aug 18, 2023 — classified as 1 injury, 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, AFTER PERFORMING DRILLING FOR A 3.5MM SCREW, WHEN REMOVING THE DRILL BIT FROM THE BONE, IT CAME OUT INCOMPLETE, THEREFORE, THE FRAGMENT COULD NOT BE RECOVERED AND REMAINED INSIDE THE PATIENT. THERE WAS NO SURGICAL DELAY AND NO PATIENT COMPLICATIONS DUE TO THE REPORTED EVENT. THIS REPORT IS FOR ONE (1) 2.8MM 3-FLUTED DRILL BIT QC/200MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17573399 ↗
• MalfunctionMay 17, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A DRILL BIT WAS FOUND BROKEN DURING DECONTAMINATION. THERE WERE NO PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.8MM 3-FLUTED DRILL BITQC/200MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8619979 ↗
• InjuryOct 5, 2018Break; Material Fragmentation; Break; Material Fragmentation

  CONCOMITANT DEVICE: PLATE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1).

  Patient problems: Foreign Body In Patient

  MAUDE report 7939446 ↗
• MalfunctionJun 21, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRILL BIT WAS FOUND BROKEN DURING DECONTAMINATION AT THE STERILE DEPARTMENT. THERE IS NO REPORTED PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR A 2.8MM 3-FLUTED DRILL BIT QC/200MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7626587 ↗