NA 388.134Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034772004), received between Sep 25, 2019 and Apr 14, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Calibration Problem” (3 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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2021Calibration Problem; Calibration Problem

  IT WAS REPORTED ON (B)(6) 2021, DURING EVALUATION AT SERVICE AND REPAIR, THE TORQUE INDICATOR WRENCH WAS FOUND TO HAVE FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) TORQUE INDICATOR WRENCH. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11664720 ↗
• MalfunctionOct 31, 2019Calibration Problem; Calibration Problem

  IT WAS REPORTED ON (B)(6) 2019, DURING EVALUATION AT SERVICE AND REPAIR, THE TORQUE INDICATOR WRENCH HAS FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) TORQUE INDICATOR WRENCH. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9262708 ↗
• MalfunctionSep 25, 2019Calibration Problem; Calibration Problem

  ON AN UNKNOWN DATE, DURING SERVICE AND REPAIR, THE TORQUE WRENCH FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) TORQUE INDICATOR WRENCH. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9119171 ↗