Torque Wrench Multi-Setting TWMRecalls & reported problems
Implant Direct Sybron Manufacturing LLC · Class 1
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10841307119265), received between Dec 20, 2019 and May 14, 2022 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Inaccurate Information” (2 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Inaccurate Information2
- Defective Component1
- Defective Device1
- Fracture1
Patient problems
- Failure of Implant3
- No Patient Involvement2
- No Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryMay 14, 2022Defective Device; Defective Device
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, THERE WAS A BROKEN/FRACTURED COMPONENT.
Patient problems: Failure of Implant
MAUDE report 14403620 ↗InjuryOct 21, 2020Fracture; Fracture
PER (B)(4) PRODUCT BROKEN/FRACTURE WAS OBSERVED.
Patient problems: Failure of Implant
MAUDE report 10709651 ↗MalfunctionApr 28, 2020Inaccurate Information; Inaccurate Information
PER COMPLAINT (B)(4), DURING A REVIEW OF FINISHED GOODS INVENTORY CURRENTLY, IT WAS DISCOVERED THAT A TORQUE WRENCH WAS PACKAGED WITH INCORRECT INSTRUCTIONS FOR USE.
Patient problems: No Patient Involvement
MAUDE report 10005302 ↗MalfunctionFeb 21, 2020Inaccurate Information; Inaccurate Information
PER COMPLAINT (B)(4), A CUSTOMER RECEIVED A TORQUE WRENCH WITH INCORRECT INSTRUCTIONS FOR USE.
Patient problems: No Patient Involvement
MAUDE report 9742519 ↗MalfunctionDec 20, 2019Defective Component; Defective Component
PER COMPLAINT (B)(4), DEFORMATION TOOK PLACE AS TORQUE WRENCH COULD NOT FIX THE IMPLANT.
Patient problems: Failure of Implant; No Information
MAUDE report 9502327 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.