NA 388.261Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10705034772233), received between Aug 13, 2019 and May 26, 2026 — classified as 32 malfunctions.

The most frequently reported specific device problem is “Calibration Problem” (30 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2026Mechanical Problem

  IT WAS REPORTED ON (B)(6) 2026, THAT, THE SYMPHONY TORQUE HANDLES WERE FEELING LOOSE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN SURGICAL DELAY. (B)(4) AND (B)(4) ARE RELATED TO EACH OTHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25278797 ↗
• MalfunctionNov 19, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE USS FINAL TIGHTENER HANDLE NEEDS TO BE RECALIBRATED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23594056 ↗
• MalfunctionAug 26, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE 10NM TORQUE WRENCH NEEDS TO BE RECALIBRATED. IT IS UNKNOWN WHEN THE ISSUE WAS OBSERVED. IT IS UNKNOWN IF THERE IS PATIENT INVOLVEMENT. IT IS UNKNOWN IF REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION OCCURRED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) HANDLE FOR HOOK OR SCREW HOLDER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20065810 ↗
• MalfunctionNov 30, 2023Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023 DURING INCOMING INSPECTION OF A LOANER SET, THE TORQUE SCREWDRIVER IN QUESTION WAS FOUND TO BE OUT OF SPECIFICATION. THE TORQUE WAS MEASURING LOWER THAN INTENDED. THERE WAS NO REPORTED PATIENT OR PROCEDURE INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 10NM TORQUE WRENCH 11MM ACROSS THE FLATS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18239027 ↗
• MalfunctionOct 21, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING EVALUATION ON AN UNKNOWN DATE, THE REPAIR TECHNICIANS FOUND THAT THIS DEVICE FAILED CALIBRATION. THE ISSUE WAS FOUND DURING TESTING AT SERVICE AND REPAIR. THIS REPORT INVOLVES ONE 10NM TORQUE WRENCH 11MM ACROSS THE FLATS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15652598 ↗
• MalfunctionOct 19, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED ON AN UNKNOWN DATE THAT DURING EVALUATION THE REPAIR TECHNICIANS FOUND THAT THIS DEVICE FAILED CALIBRATION. ISSUE FOUND DURING TESTING AT SERVICE AND REPAIR. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 10NM TORQUE WRENCH 11MM ACROSS THE FLATS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15635500 ↗
• MalfunctionSep 15, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT A 388.261,10NM TORQUE WRENCH 11MM ACROSS THE FLATS HAD FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 10NM TORQUE WRENCH 11MM ACROSS THE FLATS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15426301 ↗
• MalfunctionAug 29, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING EVALUATION AT SERVICE AND REPAIR, THE 10NM TORQUE WRENCH 11MM ACROSS THE FLATS FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 10NM TORQUE WRENCH 11MM ACROSS THE FLATS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15314316 ↗
• MalfunctionAug 18, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING EVALUATION,10NM TORQUE WRENCH 11MM ACROSS THE FLATS HAD FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 10NM TORQUE WRENCH 11MM ACROSS THE FLATS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15253119 ↗
• MalfunctionJul 14, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON ON AN UNKNOWN DATE DURING EVALUATION AT SERVICE AND REPAIR, THE HAND PIECE FOR BATTERY POWERED DRIVER HAD FAILED THE TORQUE TEST/ CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 10NM TORQUE WRENCH 11MM ACROSS THE FLATS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15011992 ↗
• MalfunctionJun 9, 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,10NM TORQUE WRENCH 11MM ACROSS THE FLATS HAD FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE 10NM TORQUE WRENCH 11MM ACROSS THE FLATS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14643335 ↗
• MalfunctionMay 4, 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 DURING EVALUATION, 10NM TORQUE WRENCH 11MM ACROSS THE FLATS HAS FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE 10NM TORQUE WRENCH 11MM ACROSS THE FLATS. THIS IS REPORT 1 OF 1 FOR COMPLAINT PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14279545 ↗
• MalfunctionMay 4, 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, THE REPAIR TECHNICIANS HAD FOUND THAT THE DEVICE HAD FAILED CALIBRATION. THIS COMPLAINT INVOLVES ONE (1) DEVICE 10NM TORQUE WRENCH 11MM ACROSS THE FLATS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14274095 ↗
• MalfunctionFeb 8, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING EVALUATION AT SERVICE AND REPAIR, THE 10NM TORQUE WRENCH WAS FOUND TO HAVE FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 10NM TORQUE WRENCH 11MM ACROSS THE FLATS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13487452 ↗
• MalfunctionSep 13, 2021Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE 10NM TORQUE WRENCH FAILED TORQUE TEST AS IT TESTED HIGH. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR (1) 10NM TORQUE WRENCH 11MM ACROSS THE FLATS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12461278 ↗
• MalfunctionMay 6, 2021Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON APRIL 12, 2021, DURING EVALUATION AT SERVICE AND REPAIR, THE 10NM TORQUE WRENCH WAS FOUND TO HAVE FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 10NM TORQUE WRENCH 11MM ACROSS THE FLATS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11784885 ↗
• MalfunctionFeb 2, 2021Calibration Problem; Calibration Problem

  THIS REPORT IS 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11266239 ↗
• MalfunctionFeb 2, 2021Calibration Problem; Calibration Problem

  THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11266235 ↗
• MalfunctionJan 25, 2021Calibration Problem; Calibration Problem

  IT WAS REPORTED ON (B)(6) 2021 THAT THE 10NM TORQUE WRENCH FAILED CALIBRATION DURING EVALUATION AT SERVICE AND REPAIR. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) 10NM TORQUE WRENCH 11MM ACROSS THE FLATS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11224077 ↗
• MalfunctionDec 9, 2020Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING INSPECTION ON AN UNKNOWN DATE, THE THREE (3) TORQUE WRENCHES WERE DISCOVERED AS NEEDED FOR RECALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 10NM TORQUE WRENCH 11MM ACROSS THE FLATS. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10976575 ↗
• MalfunctionDec 9, 2020Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING INSPECTION ON AN UNKNOWN DATE, THE THREE (3) TORQUE WRENCHES WERE DISCOVERED AS NEEDED FOR RECALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 10NM TORQUE WRENCH 11MM ACROSS THE FLATS. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10976570 ↗
• MalfunctionDec 9, 2020Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING INSPECTION ON AN UNKNOWN DATE, THE THREE (3) TORQUE WRENCHES WERE DISCOVERED AS NEEDED FOR RECALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 10NM TORQUE WRENCH 11MM ACROSS THE FLATS. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10976565 ↗
• MalfunctionAug 11, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING TESTING AT SERVICE AND REPAIR ON (B)(6) 2020, 4 10NM TORQUE WRENCHES WERE OBSERVED TO HAVE FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10392020 ↗
• MalfunctionAug 11, 2020Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING TESTING AT SERVICE AND REPAIR ON (B)(6) 2020, 4 10NM TORQUE WRENCHES WERE OBSERVED TO HAVE FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10392010 ↗
• MalfunctionAug 11, 2020Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING TESTING AT SERVICE AND REPAIR ON (B)(6) 2020, 4 10NM TORQUE WRENCHES WERE OBSERVED TO HAVE FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10391884 ↗