NA ARS1026400Recalls & reported problems
Tornier, Inc. · Torque Driver Bit · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00846832079193), received between Jun 21, 2022 and Nov 11, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Fracture” (4 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
- Fracture4
- Break3
- Device Difficult to Setup or Prepare1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 11, 2025Fracture; Fracture
IT WAS REPORTED THAT THE END OF THE DRILL BIT BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23524587 ↗MalfunctionOct 29, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
TORQUE LIMITING DRIVER WOULD NOT ENGAGE SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23413140 ↗MalfunctionNov 11, 2024Break; Fracture; Break; Fracture
THE SCREWDRIVER TIP WAS BROKEN WHILE TIGHTENING THE ASSEMBLY SCREW. AN INCORRECT (NON-TORQUE LIMITING) SCREWDRIVER HANDLE WAS USED BY MISTAKE (DURING ASSEMBLY OF THE IMPLANT).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20656116 ↗MalfunctionSep 23, 2024Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE DRIVER BIT BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20284900 ↗MalfunctionJun 21, 2022Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE TIP OF THE REVIVE TORQUE DRIVER AND T20 ASSEMBLY DRIVER BROKE DURING IMPLANT CONSTRUCTION. NO ADDITIONAL INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14761115 ↗
Other BIT, SURGICAL devices
- Tornier Perform MWJ127Tornier, Inc. · BIT, SURGICAL114 reports
- NA 310.534Synthes GmbH · BIT, SURGICAL64 reports
- NA 4200355042Stryker Corporation · BIT, SURGICAL34 reports
- ACUFEX 72204044Smith & Nephew, Inc. · BIT, SURGICAL25 reports
- NA 03.168.011Synthes GmbH · BIT, SURGICAL20 reports
- ACUFEX 72204042Smith & Nephew, Inc. · BIT, SURGICAL19 reports
- ACUFEX 72204046Smith & Nephew, Inc. · BIT, SURGICAL16 reports
- ACUFEX 72204045Smith & Nephew, Inc. · BIT, SURGICAL14 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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