NA 2366-85-000Recalls & reported problems
Depuy (Ireland) · DRILL BIT 3.8mm x 50mm · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy drill bit is used to drill into bone. Reports mostly describe it failing to cut or snapping during use, sometimes into pieces that were retrieved; the reports generally mention no patient effects. There are 33 reports, with no deaths and no injuries, and no recalls name this device.
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
- 34
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10603295120193), received between Feb 13, 2020 and Sep 25, 2026 — classified as 34 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (21 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
- Failure to Cut21
- Break13
- Material Deformation5
- Dull, Blunt1
- Material Twisted/Bent1
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions30
- Insufficient Information2
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 25 most recent of 34 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 50897056 ↗MalfunctionJun 9, 2025Break; Break
IT WAS REPORTED THAT THE DRILL BITS SNAPPED OVER TIME WHEN DRILLING BONE.
Patient problems: Insufficient Information
MAUDE report 22167024 ↗MalfunctionJun 9, 2025Break; Break
IT WAS REPORTED THAT THE DRILL BITS SNAPPED OVER TIME WHEN DRILLING BONE.
Patient problems: Insufficient Information
MAUDE report 22167011 ↗MalfunctionMay 21, 2024Break; Break
DRILL BIT BROKE IN TWO PIECES. BOTH PIECES RECOVERED, NO CONSEQUENCES FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19366355 ↗MalfunctionJan 8, 2024Break; Break
DRILL BIT SHAFT BROKE IN TWO DURING USE, BOTH ITEMS REMOVED FROM PATIENT AND PUT IN SHARPS BIN. THERE WAS NO PATIENT CONSEQUENCE OR SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18464417 ↗MalfunctionOct 25, 2023Break; Break
ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE INSTRUMENT BROKE INTO TWO PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18005748 ↗MalfunctionJul 21, 2023Break; Break
DRILL BIT HAS BROKEN THERE WERE NO SURGICAL DELAYS AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY UTILIZING A READILY AVAILABLE DRILL BIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17369961 ↗MalfunctionApr 19, 2023Failure to Cut; Failure to Cut
IT WAS REPORTED THAT DRILL BIT WAS DULL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16770301 ↗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 16738898 ↗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 16738863 ↗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 16738790 ↗MalfunctionFeb 8, 2023Break; Failure to Cut; Break; Failure to Cut
IT WAS REPORTED THE DRILL BITS EITHER SNAPPED IN HALF OR TOO BLUNT TO DRILL EFFECTIVELY. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16329175 ↗MalfunctionFeb 8, 2023Break; Failure to Cut; Break; Failure to Cut
IT WAS REPORTED THE DRILL BITS EITHER SNAPPED IN HALF OR TOO BLUNT TO DRILL EFFECTIVELY. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16327177 ↗MalfunctionFeb 8, 2023Break; Failure to Cut; Break; Failure to Cut
IT WAS REPORTED THE DRILL BITS EITHER SNAPPED IN HALF OR TOO BLUNT TO DRILL EFFECTIVELY. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16326091 ↗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 16264736 ↗MalfunctionJun 24, 2022Failure to Cut; Failure to Cut
IT WAS REPORTED THAT DRILL BIT IS BLUNT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14802459 ↗MalfunctionJun 10, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT AT THE TIME OF DRILLING THE DRILL BIT BUMPED INTO A SCREW OF THE PINNACLE CUP AND TWISTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14653969 ↗MalfunctionMay 6, 2022Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS BROKE IN TWO DURING SURGERY. THE TIP OF THE SCREW BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14305599 ↗MalfunctionApr 8, 2022Failure to Cut; Failure to Cut
DRILL BITS ARE BLUNT IN THE PINNACLE SCREW SETS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14053096 ↗MalfunctionApr 8, 2022Failure to Cut; Failure to Cut
IT WAS REPORTED THAT (B)(6) HAVE COMPLAINED TO ME ABOUT BLUNT DRILL BITS IN THEIR PINNACLE SCREW SETS, THEY WOULD LIKE TO CHANGE THEM OVER IN EACH OF THEIR PINNACLE SETS, IT IS ONLY THE SMALL AND MEDIUM DRILL BITS THAT REALLY GET USED, SO THE LONGER ONES WILL NOT NEED REPLACING. PRODUCT CODES BELOW; IT WILL BE 9 OF EACH, FOR THE 9 PINNACLE SETS. THIS PC IS CREATED TO CAPTURE THE EXTRA IPS RELATED TO (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14053012 ↗MalfunctionApr 8, 2022Failure to Cut; Failure to Cut
IT WAS REPORTED THAT (B)(6) HAVE COMPLAINED TO ME ABOUT BLUNT DRILL BITS IN THEIR PINNACLE SCREW SETS, THEY WOULD LIKE TO CHANGE THEM OVER IN EACH OF THEIR PINNACLE SETS, IT IS ONLY THE SMALL AND MEDIUM DRILL BITS THAT REALLY GET USED, SO THE LONGER ONES WILL NOT NEED REPLACING. PRODUCT CODES BELOW; IT WILL BE 9 OF EACH, FOR THE 9 PINNACLE SETS. THIS PC IS CREATED TO CAPTURE THE EXTRA IPS RELATED TO (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14053009 ↗MalfunctionApr 8, 2022Failure to Cut; Failure to Cut
IT WAS REPORTED THAT (B)(6) HAVE COMPLAINED TO ME ABOUT BLUNT DRILL BITS IN THEIR PINNACLE SCREW SETS, THEY WOULD LIKE TO CHANGE THEM OVER IN EACH OF THEIR PINNACLE SETS, IT IS ONLY THE SMALL AND MEDIUM DRILL BITS THAT REALLY GET USED, SO THE LONGER ONES WILL NOT NEED REPLACING. PRODUCT CODES BELOW; IT WILL BE 9 OF EACH, FOR THE 9 PINNACLE SETS. THIS PC IS CREATED TO CAPTURE THE EXTRA IPS RELATED TO (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14053008 ↗MalfunctionApr 8, 2022Failure to Cut; Failure to Cut
IT WAS REPORTED THAT (B)(6) HAVE COMPLAINED TO ME ABOUT BLUNT DRILL BITS IN THEIR PINNACLE SCREW SETS, THEY WOULD LIKE TO CHANGE THEM OVER IN EACH OF THEIR PINNACLE SETS, IT IS ONLY THE SMALL AND MEDIUM DRILL BITS THAT REALLY GET USED, SO THE LONGER ONES WILL NOT NEED REPLACING. PRODUCT CODES BELOW; IT WILL BE 9 OF EACH, FOR THE 9 PINNACLE SETS. THIS PC IS CREATED TO CAPTURE THE EXTRA IPS RELATED TO (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14053007 ↗MalfunctionApr 8, 2022Failure to Cut; Failure to Cut
IT WAS REPORTED THAT (B)(6) HAVE COMPLAINED TO ME ABOUT BLUNT DRILL BITS IN THEIR PINNACLE SCREW SETS, THEY WOULD LIKE TO CHANGE THEM OVER IN EACH OF THEIR PINNACLE SETS, IT IS ONLY THE SMALL AND MEDIUM DRILL BITS THAT REALLY GET USED, SO THE LONGER ONES WILL NOT NEED REPLACING. PRODUCT CODES BELOW; IT WILL BE 9 OF EACH, FOR THE 9 PINNACLE SETS. THIS PC IS CREATED TO CAPTURE THE EXTRA IPS RELATED TO (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14053004 ↗MalfunctionApr 8, 2022Failure to Cut; Failure to Cut
IT WAS REPORTED THAT (B)(6) IN (B)(6) HAVE COMPLAINED TO ME ABOUT BLUNT DRILL BITS IN THEIR PINNACLE SCREW SETS, THEY WOULD LIKE TO CHANGE THEM OVER IN EACH OF THEIR PINNACLE SETS, IT IS ONLY THE SMALL AND MEDIUM DRILL BITS THAT REALLY GET USED, SO THE LONGER ONES WILL NOT NEED REPLACING. PRODUCT CODES BELOW; IT WILL BE 9 OF EACH, FOR THE 9 PINNACLE SETS. THIS PC IS CREATED TO CAPTURE THE EXTRA IPS RELATED TO (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14053000 ↗
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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