Flexible Silicone Drill DriverRecalls & reported problems across all models
Biomet Orthopedics, LLC · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 94
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 2 models of Flexible Silicone Drill Driver by Biomet Orthopedics, LLC in the FDA's device registry (GUDID). Together they are named in 94 adverse event reports in the FDA's MAUDE database, received between Feb 10, 2020 and Jun 11, 2026 — classified as 2 injuries, 92 malfunctions.
The most frequently reported specific device problem is “Fracture” (89 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Flexible Silicone Drill Driver problems
Device problems
- Fracture89
- Crack1
- Degraded1
- Difficult to Insert1
- Material Deformation1
- Material Split, Cut or Torn1
- Material Twisted/Bent1
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions90
- Foreign Body In Patient2
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Flexible Silicone Drill Driver models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- FLEXIBLE SILICONE DRILL DRIVER 110010733BIT, DRILL65 reports
- Flexible Silicone Drill Driver 110010733BIT, DRILL29 reports
Recent Flexible Silicone Drill Driver adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗MalfunctionJan 30, 2026Fracture
NO FURTHER INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24226138 ↗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 ↗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 ↗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 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 ↗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 ↗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 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 ↗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 ↗
Other Biomet Orthopedics, LLC products
- AFFIXUSHIP FRACTURE NAIL - RIGHT39 models · 6 reports · 37 recalls
- AFFIXUSHIP FRACTURE NAIL - LEFT27 models · 7 reports · 24 recalls
- Compress Device71 models · 99 reports · 22 recalls
- Arcos Modular Revision Hip System71 models · 191 reports · 19 recalls
- Comprehensive Reverse Shoulder57 models · 895 reports · 3 recalls
- Vanguard Knee System147 models · 306 reports · 13 recalls
- STAGEONE17 models · 0 reports · 18 recalls
- StageOne Select15 models · 2 reports · 15 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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