QUICKSET 2274-45-500Recalls & reported problems
Depuy Orthopaedics, Inc. · QUICKSET 3.8mm 1 PC FLEX DRILL BIT 45mm LGT · Class 1
All models of QUICKSET (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy QuickSet flex drill bit, used in orthopedic surgery, has 211 adverse event reports, with no deaths or injuries. Most describe the drill bit breaking, sometimes while drilling screw holes, and some describe bent or dull bits. 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
- 211
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 211 adverse event reports that list this exact device (DI 10603295109211), received between Jun 29, 2017 and Sep 18, 2026 — classified as 211 malfunctions.
The most frequently reported specific device problem is “Break” (161 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
- Break161
- Material Twisted/Bent21
- Material Deformation17
- Dull, Blunt8
- Failure to Cut7
- Bent4
- Entrapment of Device4
- Corroded2
Patient problems
- No Clinical Signs, Symptoms or Conditions119
- No Consequences Or Impact To Patient78
- Insufficient Information9
- No Information6
- No Code Available3
- No Known Impact Or Consequence To Patient3
- Not Applicable2
Recent adverse event reports
The 25 most recent of 211 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Break
It was reported that during a total hip replacement surgery the drill bit broke. All parts were recovered. No patient was harmed. There was no delay in surgery. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819433 ↗MalfunctionAug 11, 2026Break
It was reported that the flex drill bit was broke while drilling screw hole.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50208242 ↗MalfunctionAug 7, 2026Break
It was reported that a few pinnacle drill bits broke through normal wear and tear. There was no patient or user harm. There was no significant delay.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50174994 ↗MalfunctionJun 1, 2026Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN AND NOT SUITABLE FOR SURGERY. THE ISSUE DID NOT OCCUR DURING SURGERY AND THERE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25355382 ↗MalfunctionJun 1, 2026Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN AND NOT SUITABLE FOR SURGERY. THE ISSUE DID NOT OCCUR DURING SURGERY AND THERE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25350879 ↗MalfunctionJun 1, 2026Break
IT WAS REPORTED THAT IT DID NOT HAPPEN IN SURGERY. INSTRUMENTS WERE BROKEN AND NOT SUITABLE FOR SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25348637 ↗MalfunctionMay 20, 2026Break
IT WAS REPORTED THAT 45MM DRILL BIT SNAPPED OFF WHEN DRILLING FOR SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25234151 ↗MalfunctionMay 1, 2026Break
IT WAS REPORTED THAT DRILL BIT BROKE DURING SURGERY. ALL BROKEN PIECES WERE REMOVED. NO ADVERSE EFFECTS TO THE PATIENT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25059605 ↗MalfunctionMar 30, 2026Break
IT WAS REPORTED THAT 3 DRILL BITS BROKE DURING THE CASE. ALL PIECES REMOVED FROM PATIENT, NO ADVERSE HEALTH EVENTS REPORTED AS A RESULT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24714234 ↗MalfunctionMar 23, 2026Break
IT WAS REPORTED THAT THE 45MM DRILL BIT BROKE OFF DURING THE CASE AND WAS SUCCESSFULLY REMOVED BY THE SURGEON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24664985 ↗MalfunctionMar 5, 2026Break
IT WAS REPORTED THAT WHILE DRILLING IN THE ACETABULUM WITH THE 45MM DRILL BIT, THE BIT BROKE AT THE TIP. IT BROKE INTO 2 PIECES AND PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24519148 ↗MalfunctionMar 3, 2026Break
IT WAS REPORTED THAT DRILL BIT BROKE. ALL PIECES WERE RETRIEVED. THERE WAS NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24497553 ↗MalfunctionJan 16, 2026Break
IT WAS REPORTED THAT BROKEN DRILL BIT SNAPPED IN HALF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24103218 ↗MalfunctionJan 5, 2026Break
IT WAS REPORTED THAT THE IMPACTED PRODUCT WAS BROKEN WHILE DRILLING FOR A SCREW. THERE WAS NO DELAYS. ALL PARTS WERE RETRIEVED FROM PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23959171 ↗MalfunctionDec 8, 2025Break; Break
IT WAS REPORTED THE DRILL BIT WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23744477 ↗MalfunctionNov 17, 2025Break; Break
IT WAS REPORTED THAT TIP OF THE DRILL BIT BROKE. WAS RETRIEVED AND THROWN AWAY IN A SHARPS BY THE HOSPITAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23575716 ↗MalfunctionOct 29, 2025Break; Break
IT WAS REPORTED THAT THE IMPACTED PRODUCT HAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23413173 ↗MalfunctionSep 10, 2025Break; Break
THE DRILL BITS FROM THE PINNACLE SCREW SET WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23015818 ↗MalfunctionSep 10, 2025Break; Break
THE DRILL BITS FROM THE PINNACLE SCREW SET WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23015736 ↗MalfunctionAug 8, 2025Break; Break
IT WAS REPORTED THAT DRILL BITS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22757684 ↗MalfunctionAug 4, 2025Break; Break
IT WAS REPORTED THAT THE DRILL BITS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22709400 ↗MalfunctionAug 4, 2025Break; Break
IT WAS REPORTED THAT THE DRILL BITS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22709320 ↗MalfunctionJul 31, 2025Break; Break
IT WAS REPORTED THAT 45MM DRILL BIT WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22674998 ↗MalfunctionJul 28, 2025Break; Break
IT WAS REPORTED THAT THE PRODUCT WAS BROKEN IN TWO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22632885 ↗MalfunctionMay 30, 2025Break; Break
IT WAS REPORTED THAT THE DRILL BIT BROKE. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22113849 ↗
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
- LCS 2366-83-000Depuy (Ireland) · BIT, DRILL207 reports
- QUICKSET 2274-52-000Depuy (Ireland) · BIT, DRILL186 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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