PINNACLE 2274-45-800Recalls & reported problems
Depuy (Ireland) · PINNACLE ONE PC REVISION DOME DRILL 45mm · Class 1
All models of PINNACLE (198)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Pinnacle 45mm revision dome drill bit is used to prepare the hip socket during replacement surgery. The 63 reports mostly describe the bit breaking or snapping during surgery, sometimes in two pieces inside the patient, and bits that would not cut or had dulled, bent or worn with use. In the accounts that give detail, the pieces were retrieved and surgery continued without harm. There are no deaths and no injuries reported. 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
- 63
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 10603295109228), received between Dec 3, 2017 and Jun 8, 2026 — classified as 63 malfunctions.
The most frequently reported specific device problem is “Break” (39 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
- Break39
- Failure to Cut21
- Material Twisted/Bent3
- Naturally Worn3
- Device-Device Incompatibility1
- Dull, Blunt1
Patient problems
- No Clinical Signs, Symptoms or Conditions38
- Insufficient Information12
- No Consequences Or Impact To Patient10
- No Code Available2
- Not Applicable2
Recent adverse event reports
The 25 most recent of 63 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 8, 2026Break
IT WAS REPORTED THAT A DRILL BIT SNAPPED. BOTH PARTS WERE RETRIEVED. AN ALTERNATIVE DRILL BIT WAS USED. NO HARM WAS CAUSED TO THE PATIENT AND THE PROCEDURE WAS CARRIED OUT WITH NO COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25428668 ↗MalfunctionApr 16, 2026Break
IT WAS REPORTED THAT 45MM DRILL BIT BROKE IN PATIENT. SURGEON WAS ABLE TO RETRIEVE BROKEN PARTS. ALL PARTS RETRIEVED. NO DELAY AS WE HAD AN EXTRA DRILL BIT. NO HARM DONE TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24899826 ↗MalfunctionApr 13, 2026Break
HIP DRILL INSTRUMENTS TO BE DAMAGED AND REQUIRE REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24865474 ↗MalfunctionJul 17, 2025Break; Break
IT WAS REPORTED THAT THERE WAS BREAKAGE AND REPAIR OF CONSIGNED ITEMS IN THE ACCOUNT FROM GENERAL USAGE. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22532164 ↗MalfunctionJan 22, 2025Break; Break
IT WAS REPORTED THAT THE DRILL BIT BROKE INTO TWO (2) PIECES DURING THE OPERATION. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21208256 ↗MalfunctionMar 25, 2024Break; Break
IT WAS REPORTED THAT THERE WAS A BROKEN DRILL BIT (45MM). SURGICAL DELAY WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18970983 ↗MalfunctionFeb 7, 2024Break; Break
IT WAS REPORTED THAT THE TWO DRILL BITS ARE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18660679 ↗MalfunctionJan 24, 2024Break; Break
IT WAS REPORTED THAT THE DRILL SNAPPED DURING CASE. BOTH ENDS WERE RETRIEVED. AN ALTERNATIVE DRILL WAS USED. PATIENT SAFE. SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18570889 ↗MalfunctionDec 13, 2023Break; Break
IT WAS REPORTED THAT THE TIP BROKE IN HALF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18321896 ↗MalfunctionDec 8, 2023Break; Break
DRILL PIECE WAS SNAPPED INTO TWO PIECES, BY SURGEON DURING THA BEING CONDUCTED. THE PIECES WERE IMMEDIATELY REMOVED AND IDENTIFIED AS WHOLE BY THE SURGEON, SCRUB NURSE AND ASSISTING NURSE. ANOTHER SCREW WAS THEN USED, WHICH WAS READILY AVAILABLE AND THERE WAS NO IMPACT TO THE PATIENT. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18293712 ↗MalfunctionNov 13, 2023Break; Break
ADDITIONAL INFORMATION WAS RECEIVED: A. DID IT BROKE INTO TWO OR MORE PIECES? 2 PIECES. B. WERE THERE ANY FRAGMENTS GENERATED? IF YES, WERE ALL THE PIECES RETRIEVED? NO FRAGMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18124875 ↗MalfunctionNov 13, 2023Break; Break
ADDITIONAL INFORMATION WAS RECEIVED: A. DID IT BROKE INTO TWO OR MORE PIECES? 2 PIECES. B. WERE THERE ANY FRAGMENTS GENERATED? IF YES, WERE ALL THE PIECES RETRIEVED? NO FRAGMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18124534 ↗MalfunctionSep 27, 2023Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE.
Patient problems: Insufficient Information
MAUDE report 17830012 ↗MalfunctionSep 27, 2023Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING HIP SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17829754 ↗MalfunctionAug 25, 2023Break; Break
T WAS REPORTED THAT THE INSTRUMENT BROKE DURING SURGERY.
Patient problems: Insufficient Information
MAUDE report 17624328 ↗MalfunctionAug 22, 2023Break; Break
IT WAS REPORTED THAT DEVICE WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17597417 ↗MalfunctionJul 6, 2023Break; Break
IT WAS REPORTED THAT THE DRILL BIT WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17270655 ↗MalfunctionJul 5, 2023Break; Break
IT WAS REPORTED THAT THE DRILL BIT HAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17257782 ↗MalfunctionMay 23, 2023Break; Break
IT WAS REPORTED THAT INSTRUMENT BROKE DURING HIP SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16987340 ↗MalfunctionNov 1, 2022Break; Break
IT WAS REPORTED THAT THE ITEM BROKE DURING HIP SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15707765 ↗MalfunctionSep 29, 2022Break; Break
IT WAS REPORTED THAT THE DRILL BIT BROKE IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15501903 ↗MalfunctionSep 29, 2022Break; Break
IT WAS REPORTED THAT DRILL BIT BROKE IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15501727 ↗MalfunctionAug 10, 2022Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT PART OF DRILL BIT JAMMED INTO THE DRILL GUIDE DURING SURGERY. NO SURGICAL DELAY. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15197664 ↗MalfunctionAug 5, 2022Break; Break
IT WAS REPORTED THAT THE INSTRUMENT IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15178213 ↗MalfunctionMay 9, 2022Break; Break
INSTRUMENT BROKE DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14338164 ↗
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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