NA 00-8790-007-03Recalls & reported problems
Zimmer, Inc. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00889024152212), received between Nov 25, 2020 and Dec 31, 2025 — classified as 1 injury, 15 malfunctions.
The most frequently reported specific device problem is “Fracture” (15 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
- Fracture15
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- Foreign Body In Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 31, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING THE HIP PROCEDURE, THE DRILL BIT BROKE WHILE INSERTING. THE GUIDE WAS USED AS REQUIRED BY SURGICAL PROCEDURE. NO PARTS LEFT IN PATIENT AND NO DELAY. ANOTHER DRILL BIT OF THE SAME SIZE WAS AVAILABLE. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23934371 ↗MalfunctionAug 4, 2025Fracture; Fracture
NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22698297 ↗MalfunctionMar 4, 2024Fracture; Fracture
IT WAS REPORTED THAT THE DRILL BITS BROKE DURING SURGERY WHILE DRILLING. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18826058 ↗MalfunctionSep 29, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING A HIP ARTHROPLASTY, THE MODULAR FLEX DRILL FRACTURED. ALL FRACTURED PIECES WERE REMOVED AND NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17844031 ↗MalfunctionAug 29, 2023Fracture; Fracture
IT WAS REPORTED THAT THE DRILL WAS BROKEN DURING A PROCEDURE. THERE WAS NO HARM OR HEALTH CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17640689 ↗MalfunctionAug 2, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING THE PROCEDURE, THE DRILL BIT FRACTURED. ALL THE PIECES WERE RECOVERED DURING THE PROCEDURE. THERE WAS NO HARM OR HEALTH CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17444526 ↗MalfunctionMar 20, 2023Fracture; Fracture
IT WAS REPORTED THAT THE DRILL WAS FOUND BROKEN ON THE INSTRUMENT TABLE WHEN GETTING OUT THE DRILL FROM THE HANDPIECE. IT WAS NOT THE FIRST USE OF THE DEVICE AND THE PATIENT WAS NOT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16574240 ↗MalfunctionFeb 22, 2023Fracture; Fracture
IT WAS REPORTED THAT THE DRILL BIT SNAPPED. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT. ANOTHER DRILL BIT WAS USED TO COMPLETE SURGERY. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16416393 ↗MalfunctionOct 4, 2022Fracture; Fracture
IT WAS REPORTED TWO CONTINUUM DRILL BITS BROKE. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION ON THE REPORTED EVENT IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15536697 ↗MalfunctionOct 4, 2022Fracture; Fracture
IT WAS REPORTED TWO CONTINUUM DRILL BITS BROKE. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION ON THE REPORTED EVENT IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15536690 ↗MalfunctionApr 20, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING AN INITIAL HIP ARTHROPLASTY, THE DRILL BIT FRACTURED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14163617 ↗MalfunctionNov 10, 2021Fracture; Fracture
IT WAS REPORTED THAT DURING AN INITIAL HIP ARTHROPLASTY, THE DRILL BIT FRACTURED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12786409 ↗MalfunctionJun 3, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11934950 ↗InjuryApr 20, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 11692490 ↗MalfunctionApr 7, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11628503 ↗MalfunctionNov 25, 2020Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10905009 ↗
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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