QUICKSET 2274-35-500Recalls & reported problems
Depuy Orthopaedics, Inc. · QUICKSET 3.8mm 1 PC FLEX DRILL BIT 35mm 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 has 773 FDA reports, including 771 malfunctions, 2 injuries and no deaths. Most reports describe the bit breaking during use, with some describing bent or twisted bits, and some mention pieces lodged in the patient. There are no recalls naming 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
- 770
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 770 adverse event reports that list this exact device (DI 10603295109174), received between Jun 23, 2017 and Sep 29, 2026 — classified as 2 injuries, 768 malfunctions.
The most frequently reported specific device problem is “Break” (545 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
- Break545
- Material Deformation96
- Material Twisted/Bent80
- Entrapment of Device37
- Bent29
- Dull, Blunt14
- Failure to Cut14
- Naturally Worn11
Patient problems
- No Clinical Signs, Symptoms or Conditions389
- No Consequences Or Impact To Patient258
- Insufficient Information62
- No Information38
- Foreign Body In Patient15
- No Code Available15
- Not Applicable12
- Device Embedded In Tissue or Plaque4
Recent adverse event reports
The 25 most recent of 770 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Break
It was reported that drill was broke when putting through the cup.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931477 ↗MalfunctionJul 9, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25764240 ↗MalfunctionJul 9, 2026Break; Illegible Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25763838 ↗MalfunctionJun 26, 2026Break
IT WAS REPORTED THAT DURING A TOTAL HIP PROCEDURE, THREE INSTRUMENTS BROKE. IT WAS REPORTED THAT SPARE DEVICES WERE AVAILABLE FOR USE AND THERE WAS NO DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25640458 ↗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 25350862 ↗MalfunctionMay 29, 2026Material Deformation
IT WAS REPORTED THAT THE TIP OF 35MM PIN FLEX DRILL BIT WAS BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25334044 ↗MalfunctionMay 29, 2026Material Deformation
IT WAS REPORTED THAT THE DRILL BIT BENT AND NEEDS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25333772 ↗MalfunctionMay 29, 2026Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN AND NOT SUITABLE FOR SURGERY. IT WAS REPORTED THAT IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25330433 ↗MalfunctionMay 29, 2026Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN AND NOT SUITABLE FOR SURGERY. IT WAS REPORTED THAT IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25330410 ↗MalfunctionMay 22, 2026Break
IT WAS REPORTED THAT DRILL BIT SNAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25255191 ↗MalfunctionMay 21, 2026Break
IT WAS REPORTED THAT THERE WERE BROKEN DRILL BITS DURING A CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25242843 ↗MalfunctionMay 19, 2026Break
IT WAS REPORTED THAT THE DRILLBIT WAS BROKEN WHILE DRILLING INTO BONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25216675 ↗MalfunctionMay 19, 2026Break
IT WAS REPORTED THAT THE 35MM DRILL BIT WAS BROKEN. IT WAS TAKEN OFF THE FIELD PRIOR TO THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25215943 ↗MalfunctionMay 11, 2026Break; Entrapment of Device
IT WAS REPORTED THAT A VOLUNTARY REPORT WAS RECEIVED (MW5186248). DURING HIP ARTHROPLASTY A DRILL BIT BROKE OFF IN THE BONE AND REMAINS EMBEDDED IN THIS PATIENT.
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 25135720 ↗MalfunctionMay 5, 2026Material Deformation
IT WAS REPORTED THAT THE CUP HANDLE DID NOT UNSCREW. IT LOCKED UP AND THE DRILL BIT BENT WHILE DRILLING. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25085837 ↗MalfunctionMay 5, 2026Material Deformation
IT WAS REPORTED THAT THE DRILL BIT HAD BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25083009 ↗MalfunctionApr 28, 2026Break
IT WAS REPORTED THAT THE 25MM DRILL BIT BROKE DURING USE. THE BROKEN PIECE WAS RETRIEVED. THERE WAS NO DELAY TO THE SURGERY. THERE WERE NO ISSUES WITH THE PATIENT AND NO ISSUES WITH THE SURGEON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25016810 ↗MalfunctionApr 24, 2026Break
IT WAS REPORTED THAT DRILL BIT SNAPPED AS SURGEON WENT TO PUSH/DRILL. NO DELAY IN CARE OR ADVERSE AFFECTS TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24984041 ↗MalfunctionApr 22, 2026Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT WHEN OPENING THE FEMORAL ADAPTER BOLT, THE PLASTIC OUTER CONTAINER OF THE BOLT PACKAGE (NOT THE CARDBOARD BOX) WAS FOUND TO BE CRACKED, BROKEN AND OTHERWISE COMPROMISED. THE PACKAGING DEFECT WAS NOT NOTICED UNTIL THE IMPLANT WAS HANDED OFF TO THE STERILE FIELD. SINCE THIS WAS ALREADY A REVISION, AND THIS WAS THE ONLY IMPLANT AVAILABLE, THE SURGEON DECIDED TO CLEAN THE IMPLANT TO THE BEST OF HIS ABILITY AND CONTINUE WITH THE SURGERY. DOE: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24954450 ↗MalfunctionApr 20, 2026Break
IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT PROCEDURE, BOTH DRILL BITS BROKE WHILE ATTEMPTING TO DRILL A HOLE IN THE PATIENTS ACETABULUM. BROKEN PIECE WAS ABLE TO BE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24924690 ↗MalfunctionApr 14, 2026Break; Entrapment of Device
IT WAS REPORTED THAT THE DRILL BIT BROKE INTO 2 PIECES WHILE THE SURGEON WAS DRILLING FOR A SCREW. THE SURGEON DID NOT RETRIEVE THE SMALL TIP OF THE BROKEN DRILL BIT AND LEFT IT IN THE PATIENT.
Patient problems: Foreign Body In Patient; Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24872572 ↗MalfunctionApr 14, 2026Break
IT WAS REPORTED THAT 35MM DRILL BIT SNAPPED IN HALF WHILE BEING USED. 25MM DRILL BIT BROKE AT THE FLEXIBLE SHAFT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24871075 ↗MalfunctionApr 13, 2026Break
IT WAS REPORTED THAT TWO (2) SCREW DRILLS BROKE WHILE DRILLING PILOT HOLES FOR THE PINNACLE SCREWS. ALL PIECES WERE RETRIEVED. THERE WAS NO PATIENT HARM OR DELAY TO THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24860747 ↗MalfunctionApr 8, 2026Break
IT WAS REPORTED THAT DURING CUP IMPLANTATION TWO DRILL BITS, SCREWDRIVER AND A SCREWDRIVER HANDLE WERE BROKEN. NO PIECES WERE LOST. RATCHET HANDLE WORKED POORLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24822109 ↗MalfunctionApr 8, 2026Break
IT WAS REPORTED THAT 35MM DRILL BIT WAS BROKEN . THE TIP BROKE OFF DRILL BIT BUT WAS RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24820313 ↗
Other BIT, DRILL devices
- QUICKSET 2274-25-500Depuy Orthopaedics, Inc. · BIT, DRILL1,985 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
- 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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