"1.5MM" SYSTEM TWIST DRILLRecalls & reported problems across all models
Biomet Microfixation, Inc · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 3 models of "1.5MM" SYSTEM TWIST DRILL by Biomet Microfixation, Inc in the FDA's device registry (GUDID). Together they are named in 30 adverse event reports in the FDA's MAUDE database, received between Apr 17, 2019 and Jul 18, 2025 — classified as 3 injuries, 27 malfunctions.
The most frequently reported specific device problem is “Fracture” (30 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 "1.5MM" SYSTEM TWIST DRILL problems
Device problems
- Fracture30
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- No Known Impact Or Consequence To Patient8
- No Information4
- Device Embedded In Tissue or Plaque1
- No Consequences Or Impact To Patient1
"1.5MM" SYSTEM TWIST DRILL models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- "1.5MM" SYSTEM TWIST DRILL 01-7149DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)14 reports
- "1.5MM" SYSTEM TWIST DRILL 01-7146DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)13 reports
- "1.5MM" SYSTEM TWIST DRILL 01-6951DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)3 reports
Recent "1.5MM" SYSTEM TWIST DRILL adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 18, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE DRILL WAS FRACTURED AND RETRIEVED DURING A PROCEDURE. ANOTHER DRILL WAS USED TO COMPLETE THE PROCEDURE. 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 22541522 ↗MalfunctionApr 24, 2025Fracture; Fracture
IT WAS REPORTED THAT THE DRILL FRACTURED DURING A PROCEDURE. THE FRACTURED DRILL TIP WAS RECOVERED FROM THE PATIENT, AND AN ALTERNATE DEVICE WAS USED TO COMPLETE THE SURGERY. NO COMPLICATIONS, INJURIES, OR SURGICAL INTERVENTIONS WERE REQUIRED, AND NO FOREIGN BODIES WERE RETAINED DUE TO THIS MALFUNCTION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21905928 ↗MalfunctionAug 27, 2024Fracture; Fracture
IT IS REPORTED THAT THE DRILL FRACTURED DURING A PROCEDURE. ALL FRAGMENTS WERE RETRIEVED AND NO HARM OR INJURY TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20076136 ↗MalfunctionFeb 1, 2024Fracture; Fracture
IT WAS REPORTED THAT THE DRILL FRACTURED DURING USE. ALL PIECES WERE REMOVED FROM THE PATIENT'S WOUND. ANOTHER DRILL WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18628585 ↗MalfunctionOct 3, 2022Fracture; Fracture
IT WAS REPORTED THAT THE DRILL FRACTURED WHEN TESTING THE ROTATION. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15528061 ↗MalfunctionSep 15, 2022Fracture; Fracture
IT WAS REPORTED THAT TWO DRILLS FRACTURED DURING DRILLING. THE FRACTURED PARTS OF BOTH DRILLS WERE EMBEDDED IN THE BONE, THE BONE AROUND THE EMBEDDED PARTS WAS SCRAPED OFF, AND ALL THE FRACTURED PARTS WERE REMOVED. THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS. THERE WERE NO ADVERSE EVENTS AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15434376 ↗MalfunctionSep 15, 2022Fracture; Fracture
IT WAS REPORTED THAT TWO DRILLS FRACTURED DURING DRILLING. THE FRACTURED PARTS OF BOTH DRILLS WERE EMBEDDED IN THE BONE, THE BONE AROUND THE EMBEDDED PARTS WAS SCRAPED OFF, AND ALL THE FRACTURED PARTS WERE REMOVED. THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS. THERE WERE NO ADVERSE EVENTS AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15434365 ↗MalfunctionAug 26, 2022Fracture; Fracture
IT WAS REPORTED THAT A DRILL TIP WAS BROKEN AND BURIED WITHIN A BONE DURING A PROCEDURE. THE DRILL TIP WAS RECOVERED. 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 15300783 ↗MalfunctionJun 27, 2022Fracture; Fracture
IT IS REPORTED THAT THE DRILL TIP BROKE DURING A PROCEDURE WITH NO HARM TO THE PATIENT. 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 14830967 ↗MalfunctionApr 11, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING A PROCEDURE THAT DRILL TIPS BROKE WHEN FIXING THE PLATE WITH A SCREW. THERE WAS A THIRTY MINUTE DELAY WHILE BROKEN DRILL TIPS WERE RETRIEVED FROM THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14073670 ↗MalfunctionApr 11, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING A PROCEDURE THAT DRILL TIPS BROKE WHEN FIXING THE PLATE WITH A SCREW. THERE WAS A THIRTY MINUTE DELAY WHILE BROKEN DRILL TIPS WERE RETRIEVED FROM THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14073658 ↗MalfunctionDec 14, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13005530 ↗MalfunctionAug 31, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12391257 ↗MalfunctionJul 27, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12227667 ↗MalfunctionJun 22, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12044085 ↗
Other Biomet Microfixation, Inc products
- TMJ SYSTEM36 models · 458 reports
- "1.5MM" SYSTEM35 models · 224 reports
- STERNALOCK BLU SYSTEM31 models · 122 reports
- 2.0 LACTOSORB SYSTEM16 models · 110 reports
- TRAUMAONE SYSTEM39 models · 80 reports
- 2.4MM SYSTEM7 models · 70 reports
- RIBFIX BLU SYSTEM19 models · 56 reports
- PECTUS SYSTEM35 models · 55 reports
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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