NA 389.471Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034775777), received between Sep 8, 2021 and Nov 4, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Calibration Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2022Calibration Problem; Calibration Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE DEVICE, FROM THE LOAN SET, FAILED INSTRUMENT TORQUE TEST DURING INSPECTION OF THE INSTRUMENTS AND THE THIRD PARTY LOGISTIC PROVIDER FACILITY. THIS REPORT INVOLVES ONE (1) 2NM TORQUE LIMITING HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15729446 ↗
• MalfunctionAug 30, 2022Calibration Problem; Calibration Problem

  DEVICE REPORT FROM HONG KONG REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 03-AUGUST-2022, THE TORQUE LIMITING HANDLE IN QUESTION FAILED A TORQUE TEST DURING INSTRUMENT INSPECTION AT THE THIRD PARTY LOGISTICS PROVIDER FACILITY. THERE WAS NO REPORTED PATIENT INTERACTION. THIS REPORT IS FOR A 2NM TORQUE LIMITING HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15319985 ↗
• MalfunctionSep 8, 2021Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, DURING A LOAN SET INSPECTION AT A THIRD PARTY LOGISTICS FACILITY INSTRUMENT TORQUE TEST WAS FAILED WITH A READING OF 2.6 NM & 2.5 NM RESPECTIVELY. THIS REPORT IS FOR ONE (1) 2NM TORQUE LIMITING HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12442812 ↗
• MalfunctionSep 8, 2021Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, DURING A LOAN SET INSPECTION AT A THIRD PARTY LOGISTICS FACILITY INSTRUMENT TORQUE TEST WAS FAILED WITH A READING OF 2.6 NM & 2.5 NM RESPECTIVELY. THIS REPORT IS FOR ONE (1) 2NM TORQUE LIMITING HANDLE WITH QUICK COUPLING. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12442811 ↗