NA 321.133Recalls & reported problems

Summary

The FDA's MAUDE database contains 194 adverse event reports that list this exact device (DI 10705034769110), received between Sep 6, 2019 and Apr 2, 2025 — classified as 1 injury, 193 malfunctions.

The most frequently reported specific device problem is “Calibration Problem” (187 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 25 most recent of 194 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE PRODUCT FAILED TORQUE TEST DURING INSPECTION AT LOCAL DC. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21757419 ↗
• MalfunctionSep 6, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING ROUTINE INCOMING INSPECTION OF A LOANER SET ON AUGUST 13, 2024, IT WAS OBSERVED THAT A TORQUE-LIMITING T-HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED LOW. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR A TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20162467 ↗
• MalfunctionSep 4, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING ROUTINE INCOMING INSPECTION OF A LOANER SET , IT WAS OBSERVED THAT A, 7 NM HANDLE, WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE DRAWING SPECIFICATION IS 7.0-8.4 NM. THE TORQUE TESTED LOW @ .87 NM THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20139019 ↗
• MalfunctionSep 4, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AUGUST 6, 2024, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE T-HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED LOW. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT INVOLVES ONE TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20134227 ↗
• MalfunctionAug 28, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON JUL 31, 2024 THE DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT 7 NM HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20092409 ↗
• MalfunctionMar 6, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING ROUTINE INCOMING INSPECTION OF A LOANER SET , IT WAS OBSERVED THAT THE TORQUE-LIMITING T-HANDLE 7NM, WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE DRAWING SPECIFICATION IS 7.0 ¿ 8.4 NM. THE TORQUE TESTED LOW ¿ 6.68 NM. THERE WAS NO PATIENT INVOLVEMENT . THIS REPORT IS FOR ONE (1) TORQUE-LIMITING T-HANDLE 7NM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18849406 ↗
• MalfunctionMar 6, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE TORQUE-LIMITING T-HANDLE 7NM WAS FOUND TO BE OUT OF SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT INVOLVES ONE (1) TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18848789 ↗
• MalfunctionJan 31, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING ROUTINE INCOMING INSPECTION OF A LOANER SET ON AN UNKNOWN DATE T, IT WAS OBSERVED THAT A TORQUE-LIMITING T-HANDLE 7NM WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR A TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18618922 ↗
• MalfunctionSep 19, 2023Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET IT WAS OBSERVED THAT MATERIAL TORQUE-LIMITING T-HANDLE 7NM, SN (B)(6) WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE DRAWING SPECIFICATION IS 7.0 NM ¿ 8.4 NM. THE TORQUE TESTED HIGH ¿ 8.41 NM. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THE PRODUCT HAS BEEN QUARANTINED AND IS AVAILABLE AND IS BEING RETURNED TO THE REPAIR SITE. A REPLACEMENT DEVICE HAS BEEN ORDERED. NO REPLACEMENT PRODUCT IS REQUIRED, AND NO SHIPPING LABEL IS REQUIRED FOR THE PRODUCT RETURN. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) TORQUE-LIMITING T-HANDLE 7NM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17772624 ↗
• MalfunctionAug 14, 2023Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING ROUTINE INCOMING INSPECTION OF THE LOANER SET, IT WAS OBSERVED THAT THE TORQUE-LIMITING T-HANDLE 7NM WAS FOUND TO BE OUT OF SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT INVOLVES ONE TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17541721 ↗
• MalfunctionJul 24, 2023Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING ROUTINE INCOMING INSPECTION OF A LOANER SET AT THE DISTRIBUTION CENTER, IT WAS OBSERVED THAT THE TORQUE LIMITING HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED LOW. THERE WAS NO KNOWN HOSPITAL OR PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4)..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17378394 ↗
• MalfunctionMar 28, 2023Calibration Problem; Calibration Problem

  IT WAS REPORTED ON AN UNKNOWN DATE THAT, DURING EVALUATION, THE REPAIR TECHNICIANS FOUND TORQUE FAILED TEST HIGH. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) TORQUE-LIMITING T-HANDLE 7NM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16630038 ↗
• MalfunctionNov 11, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING EVALUATION, THE REPAIR TECHNICIANS FOUND THE TORQUE LIMITING HANDLE IN QUESTION FAILED ITS TORQUE TEST HIGH. THERE WAS NO REPORTED PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15781060 ↗
• MalfunctionOct 17, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING EVALUATION AT SERVICE AND REPAIR, IT WAS FOUND THAT THE TORQUE-LIMITING T-HANDLE 7NM HAD FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15614601 ↗
• MalfunctionSep 2, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE DURING EVALUATION THE REPAIR TECHNICIANS FOUND THAT THIS DEVICE FAILED CALIBRATION. ISSUE FOUND DURING TESTING AT SERVICE AND REPAIR. THIS REPORT IS FOR ONE (1) TORQUE-LIMITING T-HANDLE 7NM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15352420 ↗
• MalfunctionJul 27, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF THE LOANER SET , IT WAS OBSERVED THAT THE TORQUE-LIMITING T-HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE DRAWING SPECIFICATION IS 7.32 - 8.08. THE TORQUE TESTED LOW - 6.3. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE TORQUE-LIMITING T-HANDLE 7NM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15118452 ↗
• MalfunctionJun 17, 2022Calibration Problem; Calibration Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING EVALUATION AT SERVICE AND REPAIR THE REPAIR TECHNICIANS FOUND THAT THE TORQUE-LIMITING T-HANDLE 7NM FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE TORQUE-LIMITING T-HANDLE 7NM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14731811 ↗
• MalfunctionJun 16, 2022Calibration Problem; Calibration Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING EVALUATION AT SERVICE AND REPAIR, THE TORQUE LIMITING HANDLE/QUICK FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE(1) DEVICE TORQUE LIMITING HANDLE/QUICK. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14714222 ↗
• MalfunctionJun 2, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING EVALUATION AT SERVICE AND REPAIR THE TORQUE-LIMITING T-HANDLE 7NM FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14575256 ↗
• MalfunctionFeb 11, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED ON (B)(6), 2022, DURING EVALUATION AT SERVICE AND REPAIR IT WAS FOUND THAT THE TORQUE LIMITING T-HANDLE HAD FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A TORQUE LIMITING T-HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13517272 ↗
• MalfunctionFeb 11, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING EVALUATION AT SERVICE AND REPAIR THE TORQUE-LIMITING T-HANDLE 7NM FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13517039 ↗
• MalfunctionJan 31, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET THE TORQUE HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. NO KNOWN PATIENT INVOLVEMENT. THE PRODUCT HAS BEEN QUARANTINED AND A REPLACEMENT DEVICE HAS BEEN ORDERED. THIS REPORT IS FOR ONE (1) TORQUE-LIMITING T-HANDLE 7NM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13402357 ↗
• MalfunctionJan 20, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED ON (B)(6) 2021, THE TORQUE LIMITING T-HANDLE HAD FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13306169 ↗
• MalfunctionDec 17, 2021Calibration Problem; Material Integrity Problem; Calibration Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING EVALUATION AT SERVICE AND REPAIR IT WAS FOUND OUT THAT THE HANDLE-T 7NM HAD FAILED CALIBRATION AND THE HANDLE HAS A CUT IN IT, ABOUT ¼¿ IN LENGTH. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13026694 ↗
• MalfunctionDec 16, 2021Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING EVALUATION AT SERVICE AND REPAIR, THE REPAIR TECHNICIANS FOUND THAT THE DEVICE FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13018203 ↗