NA 2366-84-000Recalls & reported problems
Depuy (Ireland) · DRILL BIT 3.8mm x 25mm · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy drill bit is a surgical drilling tool. Reports mostly describe the bit breaking or bending, often during hip replacement surgery, and some describe it failing to cut or wearing out. The 159 reports include no deaths and no injuries. No recalls name this device, and reports fell from 23 in the prior 12 months to 10 in the latest 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 159
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 159 adverse event reports that list this exact device (DI 10603295120186), received between Aug 9, 2017 and Sep 25, 2026 — classified as 159 malfunctions.
The most frequently reported specific device problem is “Break” (119 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.
Reports received per month
Most reported problems
Device problems
- Break119
- Material Deformation22
- Failure to Cut17
- Material Twisted/Bent8
- Entrapment of Device7
- Naturally Worn7
- Device-Device Incompatibility3
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Clinical Signs, Symptoms or Conditions125
- No Consequences Or Impact To Patient16
- Insufficient Information10
- Not Applicable5
- Foreign Body In Patient4
- No Information3
- No Code Available1
Recent adverse event reports
The 25 most recent of 159 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Break
It was reported that 25 mm and 50 mm drills broke in surgery. There was no reported patient or user harm. There was no significant delay. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897058 ↗MalfunctionJun 11, 2026Break
IT WAS REPORTED THAT THE CUP IMPACTOR END CAP SNAPPED OFF AND THE DRILL BIT SNAPPED. BOTH FAILURES WERE NOTICED DURING PROCESSING. THE DAMAGE WAS ATTRIBUTED TO WEAR AND TEAR. THERE WAS NO DELAY TO SURGERY. THERE WAS NO IMPACT ON THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25474475 ↗MalfunctionApr 20, 2026Break
IT WAS REPORTED THAT DURING A TOTAL HIP ARTHROPLASTY (THA), THE DRILL BIT IN QUESTION BROKE OFF DURING A LINER REPLACEMENT. IT WAS CONFIRMED THAT NO FRAGMENTS REMAINED INSIDE THE PATIENT'S BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A 30-MINUTE DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24926206 ↗MalfunctionApr 10, 2026Break
IT WAS REPORTED THAT THE DRILL BIT WAS BROKE INSIDE DRILL, AND THERE WAS NO PATIENT INVOLVEMENT RELATED TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24845202 ↗MalfunctionApr 6, 2026Material Deformation
IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT THA. DURING THE SURGERY, TWO DRILL BITS BROKE/BENT WHILE USING A DRILL FOR ACETABULAR SCREW FIXATION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24792872 ↗MalfunctionMar 5, 2026Break
IT WAS REPORTED THAT THE DRILL BIT BROKE IN TWO PIECES, WITH ALL FRAGMENTS RETRIEVED, AND ANOTHER DRILL BIT BECOMING STUCK IN THE ANGLE DRILL, RESULTING IN A 20-MINUTE PROLONGATION OF SURGERY. ALL THREE DEVICES REQUIRED REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24524186 ↗MalfunctionMar 3, 2026Break
IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT THA WITH THE DRILL BITS. DURING THE SURGERY, ONE DRILL BIT BROKE OFF AND THE OTHER BENT WHEN USING A DRILL FOR ACETABULAR SCREW FIXATION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24500954 ↗MalfunctionJan 27, 2026Break
IT WAS REPORTED THE 3.8 MM X 2 MM DRILL BIT WAS BROKEN DURING THE DRILLING OF THE ACETABULUM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24187506 ↗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 24147206 ↗MalfunctionJan 15, 2026Break
IT WAS REPORTED THAT THE DURALOC DRILL WAS CRACKED, CAUSED DRILL BIT TO BE OFF ANGLE AND BREAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24078761 ↗MalfunctionSep 2, 2025Break; Break
IT WAS REPORTED THAT DURING A PRIMARY TOTAL HIP ARTHROPLASTY, DRILL BIT WAS NOT SPINNING INDEPENDENTLY OF THE DRILL SHAFT, CAUSING TWO DRILL BITS TO BREAK. ALL BROKEN PIECES WERE RETRIEVED AND REMOVED FROM THE FIELD. THERE WERE NO COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22941466 ↗MalfunctionSep 2, 2025Break; Break
IT WAS REPORTED THAT DURING A PRIMARY TOTAL HIP ARTHROPLASTY, DRILL BIT WAS NOT SPINNING INDEPENDENTLY OF THE DRILL SHAFT, CAUSING TWO DRILL BITS TO BREAK. ALL BROKEN PIECES WERE RETRIEVED AND REMOVED FROM THE FIELD. THERE WERE NO COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22940527 ↗MalfunctionAug 20, 2025Break; Break
IT WAS REPORTED THAT WHEN THE SURGEON WAS DRILLING A HOLE FOR AN ACETABULAR SCREW, THE 25MM DRILL BIT BROKE. SURGEON WAS EASILY ABLE TO REMOVE THE BROKEN BIT WITH NO ADVERSE EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22848987 ↗MalfunctionJul 24, 2025Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT THE 25MM DRILL BIT BROKE WHEN DRILLING INTO ACETABULUM. THE SURGEON WAS UNABLE TO RETRIEVE THE BROKEN PIECE DUE TO HARD BONE. THEREFORE, THE TIP (BROKEN PART) OF THE DRILL BIT WAS LEFT IN PATIENT'S ACETABULUM BEHIND THE CUP IMPLANT.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 22588809 ↗MalfunctionJul 8, 2025Break; Break
IT WAS REPORTED THAT THE PRODUCT BROKE INTO TWO PIECES DURING HIP SURGERY. THERE WERE NO DELAYS TO SURGERY, AND NOTHING WAS LEFT IN THE PATIENT AND NO HARM WAS CAUSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22437000 ↗MalfunctionJun 24, 2025Break; Break
IT WAS REPORTED DRILL BITS HAVE BROKEN, WHILE THE SURGEON WAS DRILLING TO INSERT THE SCREW. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22318370 ↗MalfunctionJun 24, 2025Break; Break
IT WAS REPORTED DRILL BITS HAVE BROKEN, WHILE THE SURGEON WAS DRILLING TO INSERT THE SCREW. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22318267 ↗MalfunctionJun 24, 2025Break; Break
IT WAS REPORTED DRILL BITS HAVE BROKEN, WHILE THE SURGEON WAS DRILLING TO INSERT THE SCREW. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22318222 ↗MalfunctionJun 24, 2025Break; Break
IT WAS REPORTED DRILL BITS HAVE BROKEN, WHILE THE SURGEON WAS DRILLING TO INSERT THE SCREW. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22318165 ↗MalfunctionJun 9, 2025Break; Break
IT WAS REPORTED THAT THE DRILL BITS SNAPPED OVER TIME WHEN DRILLING BONE.
Patient problems: Insufficient Information
MAUDE report 22167028 ↗MalfunctionJun 9, 2025Break; Break
IT WAS REPORTED THAT THE DRILL BITS SNAPPED OVER TIME WHEN DRILLING BONE.
Patient problems: Insufficient Information
MAUDE report 22167017 ↗MalfunctionJun 4, 2025Break; Break
IT WAS REPORTED THAT THE DRILL BIT SNAPPED WHILE DRILLING A SCREW HOLE FOR THE ACETABULAR CUP. RESULTED IN ABOUT A TEN (10) MINUTE DELAY TO GET THE DRILL BIT FRAGMENT OUT OF THE PATIENT'S ACETABULUM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22140071 ↗MalfunctionJun 4, 2025Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A THA SURGERY FOR OSTEOARTHRITIS OF THE RIGHT HIP. AFTER INSERTING A PINNACLE GRIPTION CUP, THE SURGEON DRILLED WITH A DRILL BIT FOR CREATING A BURR HOLE ACCORDING TO THE SURGICAL TECHNIQUE. THE DRILL BIT WAS USED WITH A FLEXIBLE DRILL SHAFT AND DRILL GUIDE. DURING DRILLING, THE DRILL BIT BROKE OFF. THE BROKEN FRAGMENT OF THE DRILL BIT LEFT IN THE BODY WAS ABLE TO BE REMOVED QUICKLY WITH FORCEPS. IT WAS CONFIRMED BY VISUAL INSPECTION THAT NO BROKEN FRAGMENTS WERE INSIDE THE BODY, AND THE SURGERY WAS RESUMED AFTER WASHING. THE HIP JOINT WAS PHOTOGRAPHED INTRAOPERATIVELY USING PORTABLE IMAGE INTENSIFIER AND POSTOPERATIVELY USING X-RAYS, BUT NO LARGE FRAGMENTS VISIBLE TO THE NAKED EYE WERE IDENTIFIED IN THE IMAGES. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22139854 ↗MalfunctionMay 14, 2025Break; Break
ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT AND THERE WERE NO BROKEN FRAGMENTS LEFT IN THE BODY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22019121 ↗MalfunctionMay 14, 2025Break; Break
ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT AND THERE WERE NO BROKEN FRAGMENTS LEFT IN THE BODY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22019073 ↗
Other BIT, DRILL devices
- QUICKSET 2274-25-500Depuy Orthopaedics, Inc. · BIT, DRILL1,985 reports
- QUICKSET 2274-35-500Depuy Orthopaedics, Inc. · BIT, DRILL770 reports
- QUICKSET 2274-30-500Depuy Orthopaedics, Inc. · BIT, DRILL761 reports
- NA 03.037.022Synthes GmbH · BIT, DRILL339 reports
- NA 323.062Synthes GmbH · BIT, DRILL309 reports
- QUICKSET 2274-56-000Depuy (Ireland) · BIT, DRILL275 reports
- QUICKSET 2274-45-500Depuy Orthopaedics, Inc. · BIT, DRILL211 reports
- LCS 2366-83-000Depuy (Ireland) · BIT, DRILL207 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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