NA 6900854Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010484345), received between Sep 1, 2019 and Feb 11, 2022 — classified as 3 injuries, 1 malfunction.

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.

• InjuryFeb 11, 2022Break; Break

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE, THE 4.5 SOLID DRILL BROKE WHEN FIRST USED IN THE KNEE, LITTLE OR NO FORCE WAS APPLIED AT THE TIME; IT BROKE CLEAN IN TWO PIECES AND THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13511219 ↗
• InjurySep 13, 2021Break; Break

  IT WAS REPORTED THAT ON LITERATURE REVIEW "ENDOBUTTON DRILL BIT FAILURE", AN ENDOBUTTON DRILL BIT BROKE DURING A PATIENT'S SURGERY. BROKEN PIECES OF THE DRILL WERE LEFT INSIDE THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12465764 ↗
• InjuryAug 11, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, WHEN THE SURGEON DRILLED THE FEMUR, THE DRILL BIT SNAPPED WHEN IT WAS INSERTED INTO THE HOLE THAT WAS MADE WITH THE AWL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE IN THE SAME HOLE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12308343 ↗
• MalfunctionSep 1, 2019Break; Break

  IT WAS REPORTED THAT DURING THE CASE THE 4.5MM DRILL BROKE INSIDE THE PATIENT WHILST THE SURGEON WAS DRILLING FEMORAL TUNNEL. SUBSEQUENTLY, THIS CAUSED A 30 MIN DELAY IN THE PROCEDURE DUE TO REMOVING METAL DEBRIS AND REMAINING PARTS OF THE DRILL OUT OF THE PATIENTS KNEE. THIS ITEM WILL NOT BE RETURNING BACK TO THE WAREHOUSE AS IT WAS DISPOSED. A BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Information

  MAUDE report 8953108 ↗