NA 03.164.020Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982311191), received between Mar 8, 2023 and Oct 17, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE DRILL BIT BROKE IN PATIENT PELVIC WHEN USED WITH LONG DRILL GUIDE. SURGEON THOUGHT THE DRILL GUIDE AND DRILL BIT IS TOO LONG. THE BROKEN DRILL BIT IS LEFT IN PATIENT. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23324152 ↗
• MalfunctionOct 17, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE DRILL BIT BROKE IN PATIENT PELVIC WHEN USED WITH LONG DRILL GUIDE. SURGEON THOUGHT THE DRILL GUIDE AND DRILL BIT IS TOO LONG. THE BROKEN DRILL BIT IS LEFT IN PATIENT. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23324140 ↗
• MalfunctionApr 30, 2025Break; Break

  IT WAS REPORTED THAT THERE WAS A BROKEN DRILL DURING THE OPERATION. THE AREA OPERATED AREA WAS DEEP AND NOT VISIBLE, SO THE DOCTOR HAD TO SLIGHTLY PRY, CAUSING THE DRILL TO BREAK. PATIENT OUTCOME WAS GOOD. THE SURGERY WAS DELAYED BY ABOUT 30 MINUTES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21934041 ↗
• MalfunctionApr 30, 2025Break; Break

  IT WAS REPORTED THAT THERE WAS A BROKEN DRILL DURING THE OPERATION. THE OPERATED AREA WAS DEEP AND NOT VISIBLE, SO THE DOCTOR HAD TO SLIGHTLY PRY, CAUSING THE DRILL TO BREAK INTO TWO PIECES. THE PATIENT OUTCOME WAS GOOD. SURGERY WAS DELAYED BY ABOUT 30 MINUTES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21933893 ↗
• MalfunctionNov 4, 2024Break; Entrapment of Device; Break; Entrapment of Device

  ADDITIONAL INFORMATION RECEIVED STATES THAT; A. WAS OTHER MEDICAL INTERVENTION REQUIRED? - NO. B. PLEASE PROVIDE PATIENT STATUS/ OUTCOME: - DISCHARGED HOME.

  Patient problems: Foreign Body In Patient

  MAUDE report 20604767 ↗
• MalfunctionSep 11, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT THIS WAS A INTRA OPERATIVE EVENT. THE PATIENT OUTCOME WAS REPORTED TO BE FULLY RECOVER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20196198 ↗
• MalfunctionSep 5, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE DRILL BROKE DURING THE SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 20146960 ↗
• MalfunctionAug 23, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON FRIDAY (B)(6) 2024 AT 12PM A DEFECTIVE DRILL BIT BROKE AT THE TIP BEING LEFT BEHIND IN THE PATIENT. THE SURGEON MADE NO ALLEGATIONS ABOUT OUR PRODUCT AS THE PELVIC BONE WAS VERY DENSE. THE REMOVAL OF THE DRILL BIT TIP WAS THOUGHT TO BE TOO HARD TO RETRIEVE SO HE LEFT IN BONE. NO SURGICAL DELAY WAS INCURRED. APPROXIMATELY 1 CM OF DRILL BIT TIP BROKE OFF. SALES REP DON'T BELIEVE THIS WILL CAUSE ANY HARM TO THE PATIENT NOR DID THE SURGEON. HERE IS A FORMAL COMPLAINT. NO REPLACEMENT IS NEEDED AND THE ITEM ISN'T AVAILABLE TO BE RETURNED. THIS REPORT IS FOR ONE (1) DRILL BIT 2.5 QC 400 CALIBR UP TO 120. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 20056821 ↗
• MalfunctionMar 8, 2023Break; Break

  THERE WAS NO SURGICAL DELAY IN RELATION TO THE EVENT, AND THE PATIENT OUTCOME WAS GOOD. THIS REPORT INVOLVES ONE DRILL BIT Ø2.5MM QC L 400 MM CALIBR UP TO 120 MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16506400 ↗