NA 03.614.035Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 10705034715032), received between Mar 20, 2017 and Sep 14, 2026 — classified as 56 malfunctions.

The most frequently reported specific device problem is “Calibration Problem” (48 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Calibration Problem

  It was reported that the torque test failed. There was no patient harm or surgical delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50755391 ↗
• MalfunctionMay 28, 2026Calibration Problem

  IT WAS REPORTED THE TORQUE TESTING FAILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25319438 ↗
• MalfunctionMay 28, 2026Calibration Problem

  IT WAS REPORTED THE TORQUE TESTING FAILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25319404 ↗
• MalfunctionFeb 13, 2026Calibration Problem

  IT WAS REPORTED THAT DURING ANNUAL TORQUE TESTING BY THE DISTRIBUTOR, SEVERAL DEVICES FAILED. THERE WERE NO RELATED PROCEDURES, AND NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24336808 ↗
• MalfunctionFeb 13, 2026Calibration Problem

  IT WAS REPORTED THAT DURING ANNUAL TORQUE TESTING BY THE DISTRIBUTOR, SEVERAL DEVICES FAILED. THERE WERE NO RELATED PROCEDURES, AND NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24335790 ↗
• MalfunctionFeb 13, 2026Calibration Problem

  IT WAS REPORTED THAT DURING ANNUAL TORQUE TESTING BY THE DISTRIBUTOR, SEVERAL DEVICES FAILED. THERE WERE NO RELATED PROCEDURES, AND NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24335779 ↗
• MalfunctionDec 5, 2025Calibration Problem; Calibration Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THIS WAS ANNUALLY TORQUE TESTING RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23726283 ↗
• MalfunctionDec 5, 2025Calibration Problem; Calibration Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THIS WAS ANNUALLY TORQUE TESTING RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23726280 ↗
• MalfunctionDec 5, 2025Calibration Problem; Calibration Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THIS WAS ANNUALLY TORQUE TESTING RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23726278 ↗
• MalfunctionSep 13, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING TESTING THE DEVICE WAS OBSERVED TO BE OUT OF TOLERANCE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2NM TORQUE LIMITING HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20218182 ↗
• MalfunctionFeb 13, 2023Calibration Problem; Calibration Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN HONG KONG AS FOLLOWS: IT WAS REPORTED THAT ON JANUARY 19, 2023, THE DEVICE FROM THE LOAN SET FAILED INSTRUMENT TORQUE TEST DURING INSPECTION AT THE THIRD PARTY LOGISTICS PROVIDER FACILITY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 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 16362744 ↗
• MalfunctionNov 17, 2022Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM HONG KONG REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 31-AUGUST-2022, THE TORQUE SCREWDRIVER HANDLE IN QUESTION FAILED INSTRUMENT TORQUE TESTING DURING INSTRUMENT INSPECTION. NO PATIENT INTERACTION WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE. 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 15816494 ↗
• MalfunctionOct 4, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TORQUE FAILED CALIBRATION TEST LOW. THIS WAS DISCOVERED DURING EVALUATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE 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 15536082 ↗
• MalfunctionSep 19, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING EVALUATION TESTING AT THE SERVICE AND REPAIR, THE REPAIR TECHNICIANS FOUND THAT THE TORQUE TEST FAILED LOW. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE 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 15446689 ↗
• MalfunctionAug 1, 2022Calibration Problem; Calibration Problem

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE TORQUE LIMITING HANDLE NO LONGER FUNCTIONS AS INTENDED AND DOES NOT TORQUE LIMIT. THERE WERE NO PATIENT CONSEQUENCES. 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 15139310 ↗
• MalfunctionJun 17, 2022Calibration Problem; Calibration Problem

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE TORQUE LIMITING HANDLE NO LONGER FUNCTIONS AS INTENDED AND DOES NOT TORQUE LIMIT. THERE WERE NO PATIENT CONSEQUENCES. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14733826 ↗
• MalfunctionMay 23, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING EVALUATION AT SERVICE AND REPAIR, IT WAS OBSERVED THAT THE 2NM TORQUE LIMITING HANDLE - QK COUPLING DEVICE FAILED TORQUE TEST. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES ONE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14468620 ↗
• MalfunctionMay 20, 2022Calibration Problem; Calibration Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING EVALUATION AT SERVICE AND REPAIR THE 2NM TORQUE LIMITING HANDLE - QK COUPLING FAILED TORQUE TEST. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE(1) DEVICE 2NM TORQUE LIMITING HANDLE - QK COUPLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14457060 ↗
• MalfunctionJan 19, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TORQUE LIMITING HANDLE FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR 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 13293035 ↗
• MalfunctionDec 23, 2021Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING A PCF (C3-C6) FOR TREATING CERVICAL DAMAGE ON (B)(6), 2021, THE DRILL BIT BROKE. WHILE THE SURGEON WAS ADJUSTING SCREW INSERTION DIRECTION AGAINST THE HARDENED BONE, PRESSURE WAS ADDED TO THE DRILL BIT, WHICH LEAD TO TIP¿S BREAKAGE (APPROXIMATELY 16MM LONG). THE FRAGMENTED TIP WAS REMOVED FROM THE PATIENT¿S BODY. NEXT, TORQUE FEATURE ON THE TORQUE LIMITATION HANDLE BECAME OUT OF ORDER DURING ROD DEPLOYMENT. THE PROCEDURE WAS COMPLETED WITH LESS THAN THIRTY MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 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 13081889 ↗
• MalfunctionNov 23, 2021Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING EVALUATION THE 2NM TORQUE LIMITING HANDLE QUICK COUPLING HAS A FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES (1) DEVICE. THIS REPORT IS FOR (1) 2NM TORQUE LIMITING HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12862724 ↗
• MalfunctionNov 22, 2021Labelling, Instructions for Use or Training Problem; Calibration Problem; Labelling, Instructions for Use or Training Problem; Calibration Problem

  IT WAS REPORTED ON (B)(6) 2021, DURING AN EVALUATION AT SERVICE AND REPAIR IT WAS FOUND OUT THAT THE TORQUE LIMITING HANDLE QUICK COUPLING PART FAILED TORQUE TEST AND ETCH ILLEGIBLE. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2NM TORQUE LIMITING HANDLE - QK COUPLING. THIS IS REPORT 1 OF 1 FOR COMPLAINT PC-001007861.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12851407 ↗
• MalfunctionOct 12, 2021Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING EVALUATION THE REPAIR TECHNICIANS FOUND THAT THE TORQUE LIMITING HANDLE FAILED CALIBRATION TEST. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2NM TORQUE LIMITING HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12618950 ↗
• MalfunctionJun 25, 2021Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT, DURING EVALUATION AT SERVICE AND REPAIR IT WAS FOUND OUT THAT THE TORQUE LIMITING HANDLE QUICK COUPLING HAD FAILED IN CALIBRATION. THIS REPORT IS FOR ONE (1) 2NM TORQUE LIMITING HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12071546 ↗
• MalfunctionMay 26, 2021Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING EVALUATION AT SERVICE AND REPAIR IT WAS FOUND OUT THAT THE 2NM TORQUE LIMITING HANDLE HAD FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11886398 ↗