NA 2274-12-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10603295109082), received between Jan 11, 2018 and Jan 22, 2026 — classified as 38 malfunctions.

The most frequently reported specific device problem is “Break” (28 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 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2026Break

  DRILLS BROKE DURING OPERATION. ALL BITS RETRIEVED. NO LOT NUMBERS AVAILABLE. NO TIME ADDED ON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24147200 ↗
• MalfunctionJul 16, 2025Break; Break

  IT WAS REPORTED THAT THE DRILL BIT BROKE WHILE IN USE. ALL PIECES RECOVERED. NO ADVERSE CONSEQUENCES. NO SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22521030 ↗
• MalfunctionJan 30, 2024Break; Break

  IT WAS REPORTED THAT THE 40MM DRILL BIT BROKE WHILST DRILLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18605340 ↗
• MalfunctionJan 18, 2024Break; Break

  HAVE BROKEN DRILL BITS THAT HAVE SNAPPED IN 2. TIME ADDED ON 10 MINS WAITING FOR A NEW TRAY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18533917 ↗
• MalfunctionDec 18, 2023Break; Break

  IT WAS REPORTED THAT DRILL BROKE. WAS THE PRODUCT BEING USED IN A CLINICAL TRIAL? NO. DID THE EVENT HAPPEN DURING A PROCEDURE? YES. WERE YOU IN THE PROCEDURE AT THE TIME OF THE EVENT? NO. EVENT OUTCOME/HOW WAS IT MANAGED? UNKNOWN. WAS THERE ANY CONSEQUENCE TO THE PATIENT DUE TO THE EVENT? NO. WAS THE SURGERY PROLONGED DUE TO THE EVENT? NO. HAS THE REPORTER FACILITY INDICATED THERE MAY BE LEGAL ACTION? NO. PLEASE GIVE A DETAILED EXPLANATION OF THE EVENT: ITEM BROKEN INTO TWO PIECES THROUGH THE DRILL SHAFT. BOTH PIECES REMOVED AND DISPOSED OF IN A SHARPS BIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18345326 ↗
• MalfunctionSep 18, 2023Break; Failure to Cut; Break; Failure to Cut

  IT WAS REPORTED THAT THE DRILL BITS WERE BROKEN, NO PATIENT INVOLVEMENT, UNKNOWN AS TO HOW MANY PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17764851 ↗
• MalfunctionSep 18, 2023Break; Failure to Cut; Break; Failure to Cut

  IT WAS REPORTED THAT THE DRILL BITS WERE BROKEN, NO PATIENT INVOLVEMENT, UNKNOWN AS TO HOW MANY PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17764779 ↗
• MalfunctionSep 18, 2023Break; Failure to Cut; Break; Failure to Cut

  ADDITIONAL INFORMATION RECEIVED. A. DID IT BREAK INTO TWO OR MORE PIECES? NO PATIENT INVOLVEMENT. UNSURE AS TO INTO HOW MANY PIECES. B. WHICH PARTS OF THE DRILL BITS WERE BROKEN? THE SHAFTS OF THE DRILL BITS EITHER BROKE OR THE ENDS BECAME BLUNT. NO SPECIFICS FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17764486 ↗
• MalfunctionSep 18, 2023Break; Failure to Cut; Break; Failure to Cut

  ADDITIONAL INFORMATION RECEIVED. A. DID IT BREAK INTO TWO OR MORE PIECES? NO PATIENT INVOLVEMENT. UNSURE, AS TO INTO HOW MANY PIECES. B. WHICH PARTS OF THE DRILL BITS WERE BROKEN? THE SHAFTS OF THE DRILL BITS EITHER BROKE OR THE ENDS BECAME BLUNT. NO SPECIFICS FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17764396 ↗
• MalfunctionSep 18, 2023Break; Failure to Cut; Break; Failure to Cut

  ADDITIONAL INFORMATION RECEIVED. A. DID IT BREAK INTO TWO OR MORE PIECES? NO PATIENT INVOLVEMENT. UNSURE, AS TO INTO HOW MANY PIECES. B. WHICH PARTS OF THE DRILL BITS WERE BROKEN? THE SHAFTS OF THE DRILL BITS EITHER BROKE OR THE ENDS BECAME BLUNT. NO SPECIFICS FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17764302 ↗
• MalfunctionApr 25, 2023Break; Break

  IT WAS REPORTED THE DRILL IS BROKEN. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811455 ↗
• MalfunctionApr 21, 2023Naturally Worn; Naturally Worn

  INSTRUMENTS ARE WORN. NO REPORTED DELAYS OR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16784906 ↗
• MalfunctionApr 21, 2023Naturally Worn; Naturally Worn

  INSTRUMENTS ARE WORN. NO REPORTED DELAYS OR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16784892 ↗
• MalfunctionApr 21, 2023Naturally Worn; Naturally Worn

  INSTRUMENTS ARE WORN. NO REPORTED DELAYS OR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16784875 ↗
• MalfunctionApr 21, 2023Naturally Worn; Naturally Worn

  INSTRUMENTS ARE WORN. NO REPORTED DELAYS OR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16784860 ↗
• MalfunctionApr 21, 2023Naturally Worn; Naturally Worn

  INSTRUMENTS ARE WORN. NO REPORTED DELAYS OR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16784854 ↗
• MalfunctionApr 21, 2023Naturally Worn; Naturally Worn

  INSTRUMENTS ARE WORN. NO REPORTED DELAYS OR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16784697 ↗
• MalfunctionApr 13, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DEVICE IS BLUNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16739019 ↗
• MalfunctionApr 13, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DEVICE IS BLUNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16738810 ↗
• MalfunctionApr 13, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DEVICE IS BLUNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16738759 ↗
• MalfunctionApr 13, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DEVICE WAS BLUNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16738462 ↗
• MalfunctionApr 12, 2023Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT DRILL BIT SNAPPED IN HALF. NO ADVERSE EFFECTS ON PATIENT OR OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16724553 ↗
• MalfunctionJan 30, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED DRILL BITS HAD SNAPPED DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16264655 ↗
• MalfunctionDec 14, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE THA SURGERY FOR OA WITH THE DRILL BITS IN QUESTION. IN THE SURGERY, A TOTAL OF 4 DRILL BITS WERE DEFORMED OR BROKEN WHEN DRILLING SCREWS FOR THE ACETABULAR CUP. THE BONE QUALITY WAS SO HARD. THE SURGERY WAS COMPLETED SUCCESSFULLY LESS THAN 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15978804 ↗
• MalfunctionDec 14, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE THA SURGERY FOR OA WITH THE DRILL BITS IN QUESTION. IN THE SURGERY, A TOTAL OF 4 DRILL BITS WERE DEFORMED OR BROKEN WHEN DRILLING SCREWS FOR THE ACETABULAR CUP. THE BONE QUALITY WAS SO HARD. THE SURGERY WAS COMPLETED SUCCESSFULLY LESS THAN 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15978761 ↗