Flexible Silicone Drill Driver 110010733 (UDI 00887868466014)Recalls & reported problems
Biomet Orthopedics, LLC · Class 1
All models of Flexible Silicone Drill Driver (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Biomet flexible silicone drill driver is used to drill holes during hip surgery. Most of the 28 reports describe the shaft cracking, snapping or twisting while drilling, and in a few cases a broken piece was found in the patient. There are no deaths and one injury. 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00887868466014), received between Jun 29, 2022 and Jun 11, 2026 — classified as 1 injury, 28 malfunctions.
The most frequently reported specific device problem is “Fracture” (27 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
- Fracture27
- Crack1
- Difficult to Insert1
- Material Split, Cut or Torn1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 11, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT DURING A RIGHT TOTAL HIP PROCEDURE THE FLEXIBLE SILICONE DRILL DRIVER OUTER RUBBER SHEATH WAS NOTED TO BE BROKEN. THE ISSUE WAS NOTED INTRAOPERATIVELY. THERE WAS NO REPORT OF ADVERSE EVENT, PATIENT INJURY, OR PATIENT IMPACT ASSOCIATED WITH THE REPORTED DEVICE ISSUE. NO DELAY IN PROCEDURE, MEDICAL INTERVENTION, OR ADDITIONAL TREATMENT ATTRIBUTABLE TO THE EVENT WAS REPORTED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25475045 ↗MalfunctionApr 28, 2026Fracture
IT WAS REPORTED THAT DURING ACETABULAR SCREW HOLE PREPARATION THE DRILL BROKE COMPLETELY OFF. INTRA-OPERATIVELY, A DIFFERENT DRILL WAS USED TO SUCCESSFULLY COMPLETE THE CASE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25016157 ↗MalfunctionFeb 11, 2026Fracture
IT WAS REPORTED THAT A FLEXIBLE DRIVER BROKE DURING THE PROCEDURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24313353 ↗MalfunctionFeb 4, 2026Fracture
NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24257375 ↗MalfunctionOct 28, 2025Fracture; Fracture
IT WAS REPORTED THAT WHILE DRILLING HOLES, THE FLEXIBLE SILICONE DRILL DRIVER¿S SHAFT FRACTURED. THERE WAS NO PATIENT HARM OR IMPACT AS A RESULT. NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23406464 ↗MalfunctionSep 3, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE FLEXIBLE DRILL DRIVER TWISTED AND DEFORMED WHILE DRILLING FOR A SCREW. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. IT WAS REPORTED NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22950928 ↗MalfunctionAug 7, 2025Fracture; Fracture
IT WAS REPORTED THAT THE DRILL BIT SHAFT BROKE WHILE DRILLING HOLES IN THE CUP. THERE WAS NO PATIENT IMPACT, NO MEDICAL/SURGICAL INTERVENTIONS, NO SURGICAL COMPLICATIONS, NO SURGICAL DELAY, AND NO FOREIGN BODY RETAINED. THERE WERE ALSO NO CONTRIBUTING CONDITIONS RELATED TO THE REPORTED EVENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22738779 ↗MalfunctionMay 6, 2025Fracture; Difficult to Insert; Fracture; Difficult to Insert
IT WAS REPORTED THAT THE DRILL BIT DOESN¿T INSERT. THE DRILL BIT CONNECTION END OF THE FLEX DRIVER WAS FOUND TO HAVE A RETAINED FRACTURED SEGMENT DURING INVESTIGATION. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND NO SURGICAL DELAY. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21971944 ↗InjuryMar 20, 2025Fracture; Fracture
IT WAS REPORTED THE SURGEON WAS DRILLING WITH THE FLEXIBLE DRIVER WHEN IT BROKE. SOME PIECES MAY HAVE FALLEN INTO THE PATIENT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 21651313 ↗MalfunctionNov 11, 2024Fracture; Fracture
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20652151 ↗MalfunctionOct 24, 2024Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20526315 ↗MalfunctionOct 3, 2024Fracture; Fracture
IT WAS REPORTED THAT BEFORE THE SURGERY IT WAS NOTICED THAT THE RUBBER ON THE FLEXIBLE DRILL SHAFT WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20359269 ↗MalfunctionSep 17, 2024Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20238096 ↗MalfunctionAug 20, 2024Fracture; Fracture
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20004404 ↗MalfunctionMay 10, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING THE SURGERY, THE SURGEON WAS TRYING TO DRILL A SCREW HOLE, BUT WITH THE RESISTANCE OF THE BONE, THE DRILL BIT WOULD NOT TURN. THE SURGEON OPENED A BACKUP TRAY TO USE ANOTHER SILICONE DRILL DRIVER. THIS TIME, WITH THE SAME DRILL BIT BUT A DIFFERENT DRILL DRIVER IT WORKED WELL. AFTER THE SURGERY, THE SILICONE DRILL DRIVER WAS EXAMINED, AND IT WAS NOTICED THAT THE INSTRUMENT IS BROKEN AT THE JUNCTION BETWEEN THE METAL AND THE SILICONE. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19285458 ↗MalfunctionMay 6, 2024Fracture; Fracture
IT WAS REPORTED THAT THE RUBBER IS CRACKED ON THE DRILL DRIVER. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19247013 ↗MalfunctionApr 30, 2024Fracture; Fracture
IT WAS REPORTED THAT THE FLEXIBLE DRIVER FROM THE G7 EFFICIENT TRAY BROKE WHILE DRILLING SCREW HOLE FOR THE CUP. THERE WAS NO PATIENT IMPACT OR DELAY IN THE CASE. SURGERY WAS COMPLETED WITH ANOTHER DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19213144 ↗MalfunctionMar 4, 2024Fracture; Fracture
IT WAS REPORTED THAT THE FLEXIBLE SILICONE ON THE DRILL DRIVER IS STARTING TO CRACK. THE SILICONE WAS STARTING TO SPIN AND TWIST. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18829853 ↗MalfunctionJan 9, 2024Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18473819 ↗MalfunctionDec 12, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING THE PROCEDURE, THE DRILL BROKE APART WHILE DRILLING. SOME PIECES FELL INTO THE PATIENT, BUT WILL WERE RECOVERED. THERE WAS NO HARM OR HEALTH CONSEQUENCES TO THE PATIENT. IT WAS REPORTED THAT NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18310766 ↗MalfunctionDec 5, 2023Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18265297 ↗MalfunctionOct 26, 2023Fracture; Fracture
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18012631 ↗MalfunctionJul 6, 2023Fracture; Fracture
IT WAS REPORTED THE RUBBER IS COMING OFF THE FLEXIBLE SILICONE DRILL DRIVER. THERE WAS NO PATIENT INVOLVEMENT REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE, HOWEVER, NO MORE IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17271328 ↗MalfunctionMar 7, 2023Fracture; Fracture
IT WAS REPORTED THAT THE REAMER SHAFT BROKE WHILE DRILLING THROUGH HARD BONE. THE SURGERY WAS COMPLETED USING ANOTHER DEVICE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16496323 ↗MalfunctionFeb 27, 2023Crack; Fracture; Crack; Fracture
IT WAS REPORTED THAT THE SILICON DRILL DRIVER RUBBER IS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. 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 16444085 ↗
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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