MONARCH 277040510Recalls & reported problems

Summary

The FDA's MAUDE database contains 199 adverse event reports that list this exact device (DI 10705034196770), received between Aug 15, 2017 and Sep 17, 2026 — classified as 5 injuries, 194 malfunctions.

The most frequently reported specific device problem is “Calibration Problem” (125 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 199 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Calibration Problem

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

  MAUDE report 50811925 ↗
• MalfunctionApr 29, 2026Calibration Problem

  IT WAS REPORTED A DEVICE MALFUNCTION OCCURRED DUE TO FAILURE TO PASS THE TORQUE MEASUREMENT TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25034705 ↗
• MalfunctionApr 24, 2026Calibration Problem

  IT WAS REPORTED DR. STATED THAT THE TORQUES ARE APPARENTLY NOT EXERTING THE FORCE NECESSARY TO BLOCK THE LOCKING NUT ON THE BAR. WHEN THE BAR WAS TORQUED, IT CONTINUED TO MOVE ALONG THE CONSTRUCT, WHICH OBVIOUSLY SHOULD NOT HAPPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24979864 ↗
• MalfunctionApr 22, 2026Calibration Problem

  IT WAS REPORTED THE TORQUE WRENCH DID NOT EXERT THE FORCE NECESSARY TO LOCK THE LOCKING NUT ON THE BAR. WHEN THE BAR WAS TORQUED, IT CONTINUED TO MOVE ALONG THE CONSTRUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24955380 ↗
• MalfunctionApr 20, 2026Mechanical Jam

  IT WAS REPORTED THAT HANDLE WAS NOT RATCHETING. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24931946 ↗
• MalfunctionApr 20, 2026Mechanical Jam

  IT WAS REPORTED THAT HANDLES WERE NOT RATCHETING. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24931857 ↗
• MalfunctionApr 20, 2026Mechanical Jam

  IT WAS REPORTED THAT HANDLES WERE NOT RATCHETING. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24931851 ↗
• MalfunctionApr 20, 2026Mechanical Jam

  IT WAS REPORTED THAT POLY SHAFT DRIVERS ARE STRIPPED. THE HANDLES ARE NOT RATCHING. THE TAPS ARE DULL AND THE BENDERS ARE DAMAGED, METAL BENT. ROD HOLDERS WORN. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24925468 ↗
• 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 24335474 ↗
• 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 24335463 ↗
• 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 24335452 ↗
• MalfunctionFeb 12, 2026Calibration Problem

  IT WAS REPORTED THAT THE DEVICE FAILED TO PASS THE TORQUE MEASUREMENT TEST, WHICH LED TO A REQUEST FOR REPLACEMENT OF COMPONENTS IN THE KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324753 ↗
• MalfunctionFeb 3, 2026Calibration Problem

  ADDITIONAL INFORMATION RECEIVED: WHAT IS THE TIMING OF THE REPORTED EVENT? (PRE-OP, INTRA-OP, POST-OP): DURING INSPECTION AT LOCAL WAREHOUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24249256 ↗
• MalfunctionJan 13, 2026Calibration Problem

  IT WAS REPORTED THAT THE TORQUE FAILED THE TORQUE TEST AT LOCAL WAREHOUSE DURING INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24057988 ↗
• MalfunctionDec 10, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE TORQUE TEST FAILED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767496 ↗
• MalfunctionDec 10, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE TORQUE TEST FAILED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767493 ↗
• MalfunctionDec 10, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE TORQUE TEST FAILED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767490 ↗
• MalfunctionDec 10, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE TORQUE TEST FAILED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767487 ↗
• MalfunctionDec 4, 2025Calibration Problem; Calibration Problem

  ADDITIONAL INFORMATION RECEIVED: THESE IMPACTED PRODUCTS ARE RESULT FROM ANNUAL TORQUE TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23715152 ↗
• MalfunctionOct 29, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TORQUE WAS DAMAGED ON AN UNKNOWN DATE. THE HANDLE DOESN'T FIT WITH THE KEYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23416607 ↗
• MalfunctionJul 24, 2025Break; Break

  IT WAS REPORTED THAT A TORQUE WRENCH HAD AN UNEXPECTED BREAKDOWN. PATIENT WAS NOT INJURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22588259 ↗
• MalfunctionJun 9, 2025Calibration Problem; Material Twisted/Bent; Mechanical Jam; Calibration Problem; Material Twisted/Bent; Mechanical Jam

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2025. THE FINAL TORQUE WRENCH SHOULD BE TORQUING AT A SPECIFIC FORCE BUT THE SURGEON EXPERIENCED AN ABNORMALLY HIGH FORCE. THIS CAUSED A FINAL TORQUE DRIVE TO STRIP AS WELL. UPON A CLOSER LOOK, THE WRENCH LOOKS LIKE IT ISN'T WORKING PROPERLY. THE KNOB ON THE SIDE WHICH CAN USED TO REGULATE THE FORCE IS STUCK AND NOT TURNING. A SECOND WRENCH WAS ALSO NOT TORQUING PROPERLY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22170892 ↗
• MalfunctionJun 9, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2025. THE FINAL TORQUE WRENCH SHOULD BE TORQUING AT A SPECIFIC FORCE BUT THE SURGEON EXPERIENCED AN ABNORMALLY HIGH FORCE. THIS CAUSED A FINAL TORQUE DRIVE TO STRIP AS WELL. UPON A CLOSER LOOK, THE WRENCH LOOKS LIKE IT ISN'T WORKING PROPERLY. THE KNOB ON THE SIDE WHICH CAN USED TO REGULATE THE FORCE IS STUCK AND NOT TURNING. A SECOND WRENCH WAS ALSO NOT TORQUING PROPERLY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22170888 ↗
• 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 22038503 ↗
• MalfunctionApr 28, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE TORQUE HANDLE SEEMED TO TORQUE OUT AT LESS THAN 80 INCH/LBS. THE SURGEON NOTED THAT THERE WAS NOT AS MUCH FORCE REQUIRED TO TORQUE THE DRIVER AS TYPICAL. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21917694 ↗