MONARCHRecalls & reported problems across all models

We found 13 models of MONARCH by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 230 adverse event reports in the FDA's MAUDE database, received between Aug 15, 2017 and Sep 17, 2026 — classified as 8 injuries, 222 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported MONARCH problems

MONARCH models

13 models, most reported first. Each model has its own page with its reports, recalls and device details.

• MONARCH 277040510

  WRENCH
  199 reports
• MONARCH 277030110

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  8 reports
• MONARCH 277020030

  DRIVER, PROSTHESIS
  6 reports
• MONARCH 277030545

  TEMPLATE
  3 reports
• MONARCH 277050110

  EXTRACTOR
  3 reports
• MONARCH 177492060

  ORTHOSIS, SPINAL PEDICLE FIXATION
  2 reports
• MONARCH 277030500

  WRENCH
  2 reports
• MONARCH 277040525

  DRIVER, PROSTHESIS
  2 reports
• MONARCH 177440040

  ORTHOSIS, SPINAL PEDICLE FIXATION
  1 report
• MONARCH 177440060

  ORTHOSIS, SPINAL PEDICLE FIXATION
  1 report
• MONARCH 177440062

  ORTHOSIS, SPINAL PEDICLE FIXATION
  1 report
• MONARCH 177470600

  ORTHOSIS, SPINAL PEDICLE FIXATION
  1 report
• MONARCH 277030105

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 report

Recent MONARCH adverse event reports

The 15 most recent reports across all models, 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 ↗

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