NA 03.632.204Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10705034719535), received between Sep 19, 2019 and May 28, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Calibration Problem” (19 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Calibration Problem

  IT WAS REPORTED THE TORQUE TESTING FAILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25319220 ↗
• MalfunctionSep 5, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT 3.0 NM T-HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED LOW. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 3.0NM TORQUE LIMITING HANDLE WITH 4.5MM QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20146378 ↗
• MalfunctionFeb 8, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE TORQUE TESTING IT WAS OBSERVED THAT THE TORQUE HANDLE WAS FOUND TO BE OUT OF PRINT SPECIFICATION RANGE. THE PRINT SPECIFICATION RANGE IS 3.0-3.6 NM. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THE PRODUCT HAS BEEN SEGREGATED. ALL INFORMATION REGARDING THIS EVENT HAS BEEN REPORTED. THIS REPORT IS FOR ONE (1) 3.0NM TORQ LIMITING HNDL 4.5MM QK COUPLG. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18669135 ↗
• MalfunctionJul 12, 2023Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE 3.0NM TORQ LIMITING HNDL 4.5MM QK COUPLG WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT INVOLVES ONE 3.0NM TORQUE LIMITING HANDLE WITH 4.5MM QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17310709 ↗
• MalfunctionOct 18, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING EVALUATION AT SERVICE AND REPAIR IT WAS FOUND THAT THE 3.0NM TORQ LIMITING HNDL 4.5MM QK COUPLG FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 3.0NM TORQUE LIMITING HANDLE WITH 4.5MM QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15628895 ↗
• MalfunctionSep 19, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, DURING EVALUATION, THE REPAIR TECHNICIAN FOUND THAT THIS DEVICE FAILED CALIBRATION. ISSUE FOUND DURING TESTING AT SERVICE AND REPAIR. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 3.0NM TORQUE LIMITING HANDLE WITH 4.5MM QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15445250 ↗
• MalfunctionSep 16, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, DURING EVALUATION, THE REPAIR TECHNICIAN FOUND THAT THIS DEVICE FAILED CALIBRATION. ISSUE WAS FOUND DURING TESTING AT SERVICE AND REPAIR, SO THERE WAS NO PATIENT INVOLVEMENT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. THIS REPORT INVOLVES ONE 3.0NM TORQUE LIMITING HANDLE WITH 4.5MM QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15441636 ↗
• MalfunctionJul 26, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING EVALUATION AT SERVICE AND REPAIR, THE PRODUCT IN QUESTION HAD FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A 3.0NM TORQUE LIMITING HANDLE WITH 4.5MM QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15103002 ↗
• MalfunctionJun 9, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING EVALUATION AT SERVICE AND REPAIR, THE 3.0NM TORQ LIMITING HNDL 4.5MM QK COUPLG FAILED TORQUE TEST. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 3.0NM TORQ LIMITING HNDL 4.5MM QK COUPLG THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14645506 ↗
• MalfunctionJun 8, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING EVALUATION AT SERVICE AND REPAIR, THE 3.0NM TORQ LIMITING HNDL 4.5MM QK COUPLG FAILED TORQUE TEST. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) 3.0NM TORQUE LIMITING HANDLE WITH 4.5MM QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14634601 ↗
• MalfunctionJun 8, 2022Calibration Problem; Calibration Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE DEVICE FAILED TORQUE TEST. THIS REPORT IS FOR ONE (1) 3.0NM TORQ LIMITING HNDL 4.5MM QK COUPLG. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14633436 ↗
• MalfunctionApr 7, 2022Calibration Problem; Calibration Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A TESTING ON (B)(6) 2022 IT WAS FOUND THAT THE 3NM TORQUE LIMITING HANDLE IS OUT OF TOLERANCE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 3.0NM TORQUE LIMITING HANDLE WITH 4.5MM QUICK COUPLING THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14043098 ↗
• MalfunctionDec 17, 2021Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING EVALUATION AT SERVICE AND REPAIR IT WAS FOUND OUT THAT THE 3.0NM TORQUE LIMITING HANDLE 4.5MM QUICK COUPLING HAD FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 3.0NM TORQUE LIMITING HANDLE WITH 4.5MM QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13026722 ↗
• MalfunctionSep 24, 2021Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN EVALUATION BY A TECHNICIAN, THE DEVICE FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR (1) 3.0NM TORQ LIMITING HNDL 4.5MM QK COUPLG. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12528636 ↗
• MalfunctionMay 17, 2021Calibration Problem; Calibration Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE TORQUE HANDLE DID NOT MEET SPECIFICATIONS FOR TORQUE TESTING. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 3.0NM TORQUE LIMITING HANDLE WITH 4.5MM QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11836970 ↗
• MalfunctionApr 26, 2021Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING TESTING AT SERVICE AND REPAIR FOUND THAT A TORQUE LIMITING HANDLE WITH 4.5MM QUICK COUPLING FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR 1 3.0NM TORQUE LIMITING HANDLE WITH 4.5MM QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11729204 ↗
• MalfunctionSep 17, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED ON (B)(6) 2020 THAT ON AN UNKNOWN DATE THERE WAS AN ISSUE WHEN DOING THE FINAL TIGHTENING OF THE CROSS-LINK SYSTEM. THE TORQUE DID NOT CLICK AND THUS DAMAGED THE CROSS-LINK SCREW. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO SURGICAL IMPACT. THIS REPORT IS FOR ONE (1) 3.0NM TORQUE LIMITING HANDLE WITH 4.5MM QUICK COUPLING. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10551337 ↗
• MalfunctionMar 19, 2020Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING INSPECTION, A TORQUE LIMITING HANDLE WITH 4.5MM QUICK COUPLING FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9856136 ↗
• MalfunctionSep 27, 2019Calibration Problem; Calibration Problem

  IT WAS REPORTED A TORQUE LIMITING HANDLE FAILED CALIBRATION. NO KNOWN SURGICAL OR PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9130264 ↗
• MalfunctionSep 19, 2019Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING TESTING AT SERVICE AND REPAIR, A TORQUE LIMITING HANDLE WITH QUICK COUPLING FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 3.0 NM TORQUE LIMITING HANDLE WITH 4.5 MM QUICK COUPLING THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9090332 ↗