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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.