NA 03.620.061Recalls & reported problems

Summary

The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 10705034717784), received between Sep 6, 2019 and Jul 22, 2025 — classified as 78 malfunctions.

The most frequently reported specific device problem is “Calibration Problem” (76 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 78 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE WRENCH FAILED DURING THE TORQUE TESTING UPON RETURNED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22565361 ↗
• MalfunctionMay 16, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT AT A JNJ FACILITY ON AN UNKNOWN DATE, SEVERAL INSTRUMENTS FAILED A TORQUE LIMITING TEST. THE DEVICES ARE OUT OF CALIBRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038906 ↗
• MalfunctionMay 16, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT AT A JNJ FACILITY ON AN UNKNOWN DATE, SEVERAL INSTRUMENTS FAILED A TORQUE LIMITING TEST. THE DEVICES ARE OUT OF CALIBRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038892 ↗
• MalfunctionSep 9, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING ROUTINE INCOMING INSPECTION OF A LOANER SET ON (B)(6) 2024, IT WAS OBSERVED THAT, 10 NM 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 10NM TORQ LIMITING RATCHET HANDL-6MM HXC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20169488 ↗
• MalfunctionSep 5, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AUGUST 9, 2024, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET AT THE HOSPITAL, IT WAS OBSERVED THAT 10.0 NM T-HANDLE WAS OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED LOW. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) 10NM TORQUE LIMITING RATCHET HANDLE-6MM HXC. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20146321 ↗
• MalfunctionSep 5, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE T-HANDLE WAS OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT INVOLVES ONE 10NM TORQUE LIMITING RATCHET HANDLE-6MM HXC THIS IS REPORT 1 OF 1 FOR: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20146211 ↗
• MalfunctionJun 12, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE TIP OF THE SCREWDRIVER SHAFT WAS WORN AND IT WAS SLIPPING ON MATRIX. ALSO MATRIX TORQUE HANDLE FAILED HOSPITAL TORQUE TEST. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 10NM TORQUE LIMITING RATCHET HANDLE-6MM HXC THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19524009 ↗
• MalfunctionMar 21, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED ON MARCH 6, 2024, THAT UPON FINAL TIGHTENING, THE BLACK TORQUE HANDLE WOULDN'T TORQUE OUT. EVEN AFTER SWITCHING OUT DRIVER SHAFTS IT STILL WOULDN'T TORQUE OUT. THERE WAS A SURGICAL DELAY FOR 10 MINUTES. NO FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT OUTCOME. THIS REPORT IS FOR ONE (1) 10NM TORQ LIMITING RATCHET HANDL-6MM HXC THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18951916 ↗
• MalfunctionJul 12, 2023Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET AT THE MOORESVILLE, MD, DC, FACILITY, IT WAS OBSERVED THAT THE MATERIAL 10NM TORQUE LIMITING RATCHET HANDLE (6 MM HXC) WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE DRAWING SPECIFICATION IS 10 NM¿12 NM. THE TORQUE TESTED HIGH: 12.62 NM. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THE PRODUCT HAS BEEN QUARANTINED, IS AVAILABLE, AND IS BEING RETURNED TO THE REPAIR SITE. THIS REPORT IS FOR ONE (1) 10NM TORQ LIMITING RATCHET HANDL-6MM HXC THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17306618 ↗
• MalfunctionFeb 28, 2023Calibration Problem; Calibration Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED ON FEBRUARY 2, 2023, THAT THE TORQUE WAS FOUND TO BE OUT OF TOLERANCE, WHEN AN ONSITE TEST WAS DONE. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) T-HANDLE W/RATCHET-WRENCH+W/TORQ LIMIT 1. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16455800 ↗
• MalfunctionNov 23, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING EVALUATION, THE REPAIR TECHNICIANS FOUND THAT THIS DEVICE FAILED CALIBRATION. THE ISSUE WAS FOUND DURING TESTING AT SERVICE AND REPAIR. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE 10NM TORQUE LIMITING RATCHET HANDLE-6MM HXC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15851203 ↗
• MalfunctionNov 10, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING EVALUATION AT SERVICE AND REPAIR, IT WAS FOUND THAT THE 10NM TORQ LIMITING RATCHET HANDL-6MM HXC HAD FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE 10NM TORQUE LIMITING RATCHET HANDLE-6MM HXC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15770128 ↗
• MalfunctionNov 4, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING EVALUATION AT SERVICE AND REPAIR, THE 10NM TORQ LIMITING RATCHET HANDL-6MM HXC FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE 10NM TORQUE LIMITING RATCHET HANDLE-6MM HXC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15734935 ↗
• MalfunctionSep 14, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, DURING EVALUATION, THE REPAIR TECHNICIANS FOUND THAT THE DEVICE HAS FAILED CALIBRATION. ISSUE FOUND DURING TESTING OF SERVICE AND REPAIR. NO FURTHER INFORMATION. THIS REPORT IS FOR ONE (1) 10NM TORQ LIMITING RATCHET HANDL-6MM HXC THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15419007 ↗
• MalfunctionAug 30, 2022Calibration Problem; Calibration Problem

  DEVICE REPORT FROM HONG KONG REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE TORQUE LIMITING HANDLE IN QUESTION FAILED THE INSTRUMENT TORQUE TEST DURING INSTRUMENT INSPECTION AT THE THIRD PARTY LOGISTICS PROVIDER FACILITY. THERE WAS NO REPORTED PATIENT INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 10NM TORQUE LIMITING RATCHET HANDLE-6MM HXC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15320115 ↗
• MalfunctionAug 26, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING EVALUATION AT SERVICE AND REPAIR, THE 10NM TORQ LIMITING RATCHET HANDL-6MM HXC FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 10NM TORQ LIMITING RATCHET HANDL-6MM HXC THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15303050 ↗
• MalfunctionAug 1, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE PRODUCT IN QUESTION WAS OUT OF SPEC. THE TORQUE TESTED LOW (9.88 NM, DRAWING SPEC IS 10-12 NM). THERE IS NO KNOWN HOSPITAL OR PATIENT INVOLVEMENT. THIS REPORT IS FOR A 10NM TORQUE LIMITING RATCHET HANDLE-6MM HXC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15141290 ↗
• MalfunctionJul 25, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, DURING EVALUATION AT SERVICE AND REPAIR ONE (1)10NM TORQ LIMITING RATCHET HANDL-6MM HXC HAD FAILED THE TORQUE TEST. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) 10NM TORQUE LIMITING RATCHET HANDLE-6MM HXC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15093947 ↗
• MalfunctionJul 1, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 DURING A POSTERIOR LUMBAR FUSION PROCEDURE, AT THE END OF THE CASE, WHEN FINAL TIGHTENING OR TORQUEING THE LAST SET SCREW THE TORQUE HANDLE KEPT SPINNING AND TIGHTENING THE SET SCREW BUT NEVER TORQUED OUT. FINALLY THE AMOUNT OF PRESSURE ON THE SCREW CAUSED IT TO PULL OUT OF THE PEDICLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE HELP OF ANOTHER TORQUE HANDLE. THERE WAS FIFTEEN TO TWENTY (15-20) MINUTES OF SURGICAL DELAY OCCURRED. THIS REPORT IS FOR ONE (1) 10NM TORQUE LIMITING RATCHET HANDLE-6MM HXC. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14886796 ↗
• MalfunctionJun 13, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING EVALUATION AT SERVICE AND REPAIR, THE 10NM TORQ LIMITING RATCHET HANDL-6MM HXC FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 10NM TORQ LIMITING RATCHET HANDL-6MM HXC THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14676492 ↗
• MalfunctionJun 10, 2022Calibration Problem; Calibration Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE,10NM TORQ LIMITING RATCHET HANDL-6MM HXC WAS TEST FAILED. IT WAS UNKNOWN WHEN WAS THE EVENT OCCURRED. PATIENT AND PROCEDURE INVOLVEMENT ARE UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE 10NM TORQ LIMITING RATCHET HANDL-6MM HXC. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14654491 ↗
• MalfunctionJun 10, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING EVALUATION AT SERVICE AND REPAIR THE REPAIR TECHNICIANS FOUND THAT THE10NM TORQ LIMITING RATCHET HANDL-6MM HXC FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 10NM TORQ LIMITING RATCHET HANDL-6MM HXC THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14653662 ↗
• MalfunctionJun 10, 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 THE10NM TORQ LIMITING RATCHET HANDL-6MM HXC FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE(1) DEVICE 10NM TORQ LIMITING RATCHET HANDL-6MM HXC. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14653538 ↗
• MalfunctionJun 8, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, DURING EVALUATION AT SERVICE AND REPAIR, THE REPAIR TECHNICIAN FOUND OUT THAT THE 10NM TORQ LIMITING RATCHET HANDL-6MM HXC FAILED TORQUE TEST. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 10NM TORQ LIMITING RATCHET HANDL-6MM HXC THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14630834 ↗
• MalfunctionJun 8, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING EVALUATION AT SERVICE AND REPAIR, THE 10NM TORQ LIMITING RATCHET HANDL-6MM HXC FAILED TORQUE TEST. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 10NM TORQ LIMITING RATCHET HANDL-6MM HXC. THIS IS REPORT 1 OF 1 FOR COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14630811 ↗