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Torque Wrench TWRecalls & reported problems

Implant Direct Sybron Manufacturing LLC · Torque Wrench · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841307123637), received between Nov 28, 2019 and Nov 28, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

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

  • Device-Device Incompatibility1

Patient problems

  • Failure of Implant1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 28, 2019Device-Device Incompatibility; Device-Device Incompatibility

    PER COMPLAINT (B)(4), TORQUE WRENCH ADAPTER DID NOT ENGAGE PROPERLY.

    Patient problems: Failure of Implant; No Consequences Or Impact To Patient

    MAUDE report 9389864 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.