NA 03.010.036Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982067098), received between Mar 22, 2017 and Sep 24, 2022 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, BLACK LIQUID BEGAN TO COME OUT OF THE GUIDE WHEN THE DRILL BIT WAS INSERTED. THERE WAS NO REPORTED PATIENT IMPACT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR A 12.0MM CANNULATED DRILL BIT LARGE QC/190MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15477358 ↗
• MalfunctionApr 25, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT THE DRILL BIT DEVICES WERE DULL. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) 12.0 CANNULATED DRILL BIT LARGE QC/190 DEVICE. THIS COMPLAINT INVOLVES 2 DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14193555 ↗
• MalfunctionApr 25, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER IN CANADA THAT THE DRILL BIT DEVICES WERE DULL. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) 12.0 CANNULATED DRILL BIT LARGE QC/190 DEVICE. THIS COMPLAINT INVOLVES 2 DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14193545 ↗
• MalfunctionNov 12, 2021Break; Break

  IT WAS REPORTED THAT, DURING REVERSE LOGISTICS AUDIT OF A RETURNED DEVICE AT MILLSTONE THE 12.0 CANNULATED DRILL BIT LARGE QC/190 WAS FOUND TO BE BROKEN . NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 12.0 CANNULATED DRILL BIT LARGE QC/190. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12804600 ↗
• MalfunctionJan 19, 2018Break; Break

  IT WAS REPORTED THAT DURING TIBIAL NAIL EX OPENING PROCEDURE, DRILL BIT QUICK CONNECT BROKE APART FROM OPENING REAMER. THERE WAS NO DELAY IN THE PROCEDURE AND PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT WAS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: NON-SYNTHES DRILL BIT (PART/LOT UNKNOWN, QUANTITY 1). (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7207002 ↗
• MalfunctionMar 22, 2017Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2017, DURING AN UNKNOWN SURGERY, WHILE A SURGEON WAS ATTEMPTING TO OPEN THE PROXIMAL TIBIA WITH THE 12MM OPENING REAMER; THE 12MM CANNULATED DRILL BIT BROKE WHERE IT WAS ATTACHED TO THE JACOB'S CHUCK. THE BROKEN PIECE WAS RETRIEVED FROM THE JACOB'S CHUCK AND THE SURGEON USED THE 12MM AWL TO CONTINUE OPENING THE PROXIMAL TIBIA. THE SURGERY WAS DELAYED 10 MINUTES SO THE STAFF COULD FIND AN ALTERNATIVE DEVICE TO COMPLETE THE SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO ADDITIONAL MEDICAL INTERVENTION REQUIRED. THE BROKEN DRILL BIT WILL NOT BE RETURNED FOR INVESTIGATION. CONCOMITANT DEVICE REPORTED: JACOB'S CHUCK (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6425519 ↗