PINNACLE 2274-81-000Recalls & reported problems
Depuy (Ireland) · PINNACLE ONE PC REVISION PERIPHERAL DRILL · Class 1
All models of PINNACLE (198)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Pinnacle peripheral drill bit is used to drill screw holes during hip replacement surgery. The 30 adverse event reports mostly describe the drill bit breaking during use, sometimes into pieces that had to be removed from the patient, along with bits going dull and failing to cut. No deaths or injuries were reported, 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
- 29
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10603295109433), received between Dec 7, 2017 and May 13, 2026 — classified as 29 malfunctions.
The most frequently reported specific device problem is “Break” (26 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
- Break26
- Entrapment of Device2
- Device Contamination with Chemical or Other Material1
- Dull, Blunt1
- Failure to Cut1
- Fracture1
- Material Deformation1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- No Consequences Or Impact To Patient11
- Foreign Body In Patient2
- Insufficient Information2
- Not Applicable1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2026Break
IT WAS REPORTED THAT THE DRILL BIT BROKE WHILE DRILLING FOR THE SCREW. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25163960 ↗MalfunctionFeb 4, 2026Break
IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT PROCEDURE, THE DRILL BIT WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24257518 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENT'S TIP BROKE WHILE DRILLING. ALL PARTS WERE RETRIEVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23434946 ↗MalfunctionOct 21, 2025Break; Break
IT WAS REPORTED THAT THE DRILL BIT WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23351570 ↗MalfunctionDec 4, 2024Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT A DRILL BIT BROKE POSTOPERATIVELY. X-RAYS REVEALED THAT THE DRILL BIT FRAGMENT HAD NOT BEEN RETRIEVED. UNKNOWN SURGICAL DELAY.
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 20844151 ↗MalfunctionOct 28, 2024Break; Break
IT WAS REPORTED THAT THE DRILL BIT BROKE DURING USE. ALL PIECES WERE RETRIEVED. THERE WAS NO SURGICAL DELAY. THERE WERE NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20544048 ↗MalfunctionSep 17, 2024Break; Break
ADDITIONAL INFORMATION WAS RECEIVED: IN REGARD TO REAMERS NO NORMAL WEAR AND TEAR AND IN REGARD TO DRILL BITS NO ALL PIECES RECOVERED QUICKLY. IN REGARD TO PERIPERAL REVISION DRILL BIT, IT WAS CONFIRMED THAT ADVERSE EFFECTS OCCURRED ON THE PATIENT. THE REVISION SURGEON WAS NOT ABLE TO PUT PERIPHERAL SCREWS IN AS HE WOULD HAVE LIKED. THE PERIPHERAL DRILL BIT BROKE IN 2X PIECES AND WERE ALL RECOVERED. THE DOME HOLE DRILL BIT WAS DULL. WE JUST WENT UP A SIZE IN DRILL BIT (NO NOTICEABLE DELAY).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20235170 ↗MalfunctionAug 5, 2024Break; Break
IT WAS REPORTED THAT THE DRILL IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19905753 ↗MalfunctionJul 25, 2024Break; Break
IT WAS REPORTED THAT THE DRILL BIT BROKE AT TIP, ALL PARTS RETRIEVED.
Patient problems: Insufficient Information
MAUDE report 19825921 ↗MalfunctionDec 6, 2023Break; Material Deformation; Break; Material Deformation
IT WAS REPORTED THAT THE DRILL BIT IS BENT AND BROKEN IN TWO PIECES. IT IS UNKNOWN IF THE SURGERY WAS DELAYED DUE TO THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18274098 ↗MalfunctionNov 28, 2023Break; Break
ADDITIONAL INFORMATION WAS RECEIVED AND STATED. A. PLEASE CONFIRM, ABOUT SURGICAL DELAY? THERE WAS NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18218397 ↗MalfunctionJul 19, 2023Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT DURING A REVISION SURGERY IN WHICH THE COMPONENTS OF THE ACETABULUM AND THE HEAD OF THE SAID IMPLANT WERE REPLACED, A PIN REV PERIPH DRILL (REUSABLE ITEM) WAS USED FOR DRILLING, AMONG OTHER THINGS. DURING THE USE OF THE DRILL IT BROKE IN THE PATIENT'S BODY. THE SURGEON DECIDED NOT TO REMOVE THE BROKEN PART OF THE DRILL FROM THE PATIENT'S BODY AND COMPLETED THE OPERATION WITH ANOTHER DRILL OF A MATCHING DIAMETER FOR THE IMPLANT FIXATION. ACCORDING TO THE SURGEON, NO FURTHER MEDICAL INTERVENTION IS PLANNED AT THIS STAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17353236 ↗MalfunctionOct 31, 2022Break; Break
ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE TIP OF THE DRILL BIT BROKE INTO TWO PIECES. IT BROKE BECAUSE THE SURGEON OVER TORQUED THE DRILL BIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15699237 ↗MalfunctionAug 22, 2022Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE PINNACLE REVISION PERIPHERAL SCREW DRILL BIT IS DULL. DRILL BIT BROKE WHILE ATTEMPTING TO DRILL FOR A PERIPHERAL SCREW. A SECONDARY DRILL BIT WAS USED TO COMPLETE THE PROCEDURE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15266005 ↗MalfunctionApr 27, 2022Break; Break
IT WAS REPORTED THAT THE TWO REVISION SCREW DRIVERS WERE BROKEN WHEN PREPPING FOR BUTTRESS. THERE WAS NO DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14219784 ↗MalfunctionApr 27, 2022Break; Break
IT WAS REPORTED THAT THE TWO REVISION SCREW DRIVERS WERE BROKEN WHEN PREPPING FOR BUTTRESS. THERE WAS NO DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14219781 ↗MalfunctionOct 23, 2020Break; Break
IT WAS REPORTED THAT THE PERIPHERAL DRILL BIT BROKE WHILE PLACING SCREWS. IT BROKE IN THE MIDDLE OF THE FLUTED TIP. ALL PIECES WERE REMOVED. ALSO, THE RIGID HEX DRIVER WAS STRIPPED DURING TRIALING. NO PIECES WERE BROKEN OFF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10730750 ↗MalfunctionApr 27, 2020Break; Break
THE INSTRUMENTS WERE REPORTED FOR UNKNOWN REASON. FOUND IN OFFICE SETS AND NO SURGERY WAS EFFECTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10002439 ↗MalfunctionApr 3, 2020Break; Break
IT WAS REPORTED THAT THE TOP OF DRILL BIT BROKE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9924191 ↗MalfunctionJun 18, 2019Break; Break
IT WAS REPORTED THAT THE PERIPHERAL DRILL BIT BROKE, ALL PIECES WERE REMOVED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8708554 ↗MalfunctionMay 17, 2019Break; Fracture; Break; Fracture
IT WAS REPORTED THAT DURING A PINNACLE REVISION, A DRILL BIT WAS BROKEN WITH A REVISION CUP IN AND MULTIPLE SCREWS IN. THE SURGEON DETERMINED IT IS BEST TO LEAVE THE PART OF THE BIT INSTEAD OF HARMING THE PELVIS MORE BY TAKING THE CUP OUT AND DIGGING FOR IT. NO FURTHER PATIENT INFORMATION IS AVAILABLE AT THIS TIME. DRILL BIT WILL NOT BE RETURNED AS IT IS BEING SENT TO RISK MANAGEMENT.
Patient problems: Foreign Body In Patient
MAUDE report 8619422 ↗MalfunctionMar 29, 2019Material Twisted/Bent; Material Twisted/Bent
MalfunctionMar 1, 2019Break; Device Contamination with Chemical or Other Material; Break; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT WHILE DRILLING FOR A PINNACLE REVISION PERIPHERAL SCREW PART OF THE DRILL BIT WAS BROKE OFF INSIDE THE PATIENT. THE SURGEON CHOSE TO LEAVE IT IN THE PATIENT. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8382657 ↗MalfunctionJan 2, 2019Break; Break
IT WAS REPORTED THAT THE INCREDIBLE BONE QUALITY BROKE MULTIPLE DRILL BITS WHILE TRYING TO DRILL THROUGH THIS PATIENTS BONE FOR SCREWS IN THE ACETABULAR SHELL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8210448 ↗MalfunctionNov 15, 2018Break; Break
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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