NA 03.641.002Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034720104), received between Aug 14, 2020 and Nov 10, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Calibration Problem” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2023Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, DURING INCOMING INSPECTION OF A LOAN SET, THE TORQUE HANDLE IN QUESTION WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE ACTUAL TORQUE VALUES MEASURED WERE HIGHER THAN THE SPECIFICATION RANGE. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 5NM TORQUE LIMITING HANDLE 6MM HXC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18110149 ↗
• MalfunctionJul 24, 2023Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING ROUTINE INSPECTION OF THE LOANER SET AND THE DISTRIBUTION CENTER, THE 5NM TORQUE LIMITING HANDLE WAS FOUND TO BE OUT OF SPECIFICATION. THE TORQUE TESTED LOW. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT INVOLVES ONE 5NM TORQUE LIMITING HANDLE 6MM HXC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17378827 ↗
• MalfunctionJun 7, 2023Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT 5/23/2023 DURING ROUTINE INCOMING INSPECTION OF A LOANER SET AT THE (B)(6), IT WAS OBSERVED THAT TORQUE LIMITING HANDLE 6MM HXC WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED LOW. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. ALL INFORMATION REGARDING THIS EVENT HAS BEEN REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 5NM TORQUE LIMITING HANDLE 6MM HXC THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17083221 ↗
• MalfunctionOct 5, 2021Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING EVALUATION THE REPAIR TECHNICIANS FOUND THAT THE HANDLE WITH TORQUE LIMITER, 5NM FOR HEXAGONAL COUPLING FAILED THE TORQUE TEST. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR (1) 5NM TORQUE LIMITING HANDLE 6MM HXC. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12579695 ↗
• MalfunctionAug 17, 2021Calibration Problem; Calibration Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A INSPECTION IT WAS IDENTIFIED THAT THE DEVICE FAILED THE TORQUE TEST. NO PATIENT OR HOSPITAL INVOLVED. THIS REPORT IS FOR ONE (1) 5NM TORQUE LIMITING HANDLE 6MM HXC THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12333246 ↗
• MalfunctionAug 14, 2020Calibration Problem; Calibration Problem

  IT WAS REPORTED ON (B)(6) 2020, DURING EVALUATION AT SERVICE AND REPAIR IT WAS FOUND OUT THAT THE TORQUE LIMITING HANDLE HAD FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) 5NM TORQUE LIMITING HANDLE 6MM HXC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10408288 ↗