FLEXIBLE SILICONE DRILL DRIVER 110010733 (UDI 00880304569126)Recalls & reported problems
Biomet Orthopedics, LLC · Class 1
All models of Flexible Silicone Drill Driver (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Biomet flexible silicone drill driver is a surgical drill bit used in bone procedures. The 64 reports mostly describe the shaft or drill breaking during surgery, in one case leaving a metal fragment in the patient that was later removed, and another describing the shaft snapping into two pieces. One injury was reported and no deaths. There are no recalls naming this device, and reports have dropped sharply, from 17 in the prior 12 months to 1.
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
- 65
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 00880304569126), received between Feb 10, 2020 and May 19, 2026 — classified as 1 injury, 64 malfunctions.
The most frequently reported specific device problem is “Fracture” (62 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture62
- Degraded1
- Material Deformation1
- Naturally Worn1
- Positioning Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions62
- Foreign Body In Patient1
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 19, 2026Fracture
IT WAS REPORTED THAT A SCREWDRIVER SHAFT BROKE. 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 25217600 ↗MalfunctionJan 30, 2026Fracture
NO FURTHER INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24226138 ↗MalfunctionOct 7, 2025Fracture; Fracture
IT WAS REPORTED THAT THE FLEXIBLE DRILL FRACTURED DURING THE CASE. THERE WAS NO PATIENT HARM OR INJURY DUE TO THIS MALFUNCTION. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23232592 ↗MalfunctionAug 13, 2025Fracture; Fracture
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22797244 ↗MalfunctionJul 17, 2025Fracture; Fracture
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22532588 ↗MalfunctionJul 2, 2025Fracture; Fracture
IT WAS REPORTED THAT THE DRILL DRIVER FRACTURED DURING DRILLING. NO PATIENT INVOLVEMENT WAS REPORTED. NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22381795 ↗MalfunctionMay 1, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING THE SURGERY, THE FLEXIBLE DRILL DRIVER SHAFT BROKE INTO TWO PIECES. 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 21941288 ↗MalfunctionApr 24, 2025Fracture; Fracture
IT WAS REPORTED THAT THE FLEXIBLE DRILL GUIDE BROKE. 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 21901844 ↗MalfunctionApr 22, 2025Fracture; Fracture
IT WAS REPORTED THAT A METAL SHARD FROM THE INSERTER WAS FOUND IN THE PATIENT ON X-RAY AND SUBSEQUENTLY WAS REMOVED. THERE WERE NO FURTHER MEDICAL INTERVENTIONS NECESSARY. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21880962 ↗MalfunctionApr 21, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21872329 ↗MalfunctionMar 26, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21700440 ↗MalfunctionFeb 26, 2025Fracture; Fracture
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21469344 ↗MalfunctionFeb 18, 2025Fracture; Fracture
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21406234 ↗MalfunctionJan 14, 2025Fracture; Fracture
IT WAS REPORTED THAT THE DRILL BIT FRACTURED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21152526 ↗MalfunctionDec 17, 2024Fracture; Fracture
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20954876 ↗MalfunctionDec 9, 2024Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20877844 ↗MalfunctionNov 19, 2024Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20726299 ↗MalfunctionNov 15, 2024Fracture; Fracture
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20693734 ↗MalfunctionNov 6, 2024Fracture; Fracture
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20623012 ↗MalfunctionOct 21, 2024Fracture; Fracture
IT WAS REPORTED THAT THE FLEXIBLE DRILL SHEATH STARTED TO SHED AND WAS REJECTED BY THE OPERATIONAL ROOM STAFF FOR POTENTIAL CONTAMINATION CONCERNS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20495066 ↗MalfunctionSep 10, 2024Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20183547 ↗MalfunctionJul 17, 2024Fracture; Fracture
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19766570 ↗MalfunctionJul 1, 2024Fracture; Fracture
IT WAS REPORTED THAT THE FLEXIBLE DRILL SHAFT COATING IS CRACKED. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. IT WAS REPORTED THAT NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19643934 ↗MalfunctionJun 7, 2024Material Deformation; Material Deformation
THE BROKEN FLEXIBLE DRILL DRIVER WAS RETURNED WITH NO IDENTIFYING ACCOUNT, EVENT, OR SURGEON INFORMATION. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS. NO ADDITIONAL INFORMATION WAS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 19489880 ↗MalfunctionJun 5, 2024Fracture; Naturally Worn; Fracture; Naturally Worn
IT WAS REPORTED THAT WHEN OPENING UP THE INSTRUMENT, THE DRILL DRIVER WAS FOUND WORN AND BROKEN. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19469126 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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