NA 03.835.043Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10705034817569), received between Oct 4, 2019 and Jan 27, 2025 — classified as 46 malfunctions.

The most frequently reported specific device problem is “Calibration Problem” (46 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 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHILE DOING A 3 LEVEL ALIF CASE, AT THE SECOND LEVEL, L4-5, SURGEON WAS IMPLANTING A SYNFIX EVO CAGE. WHEN INSERTING THE THIRD SCREW INTO THE IMPLANT, THE DRIVER BECAME HARD TO TURN NEAR THE END OF FINAL TIGHTENING THE SCREW INTO THE INTEGRATED PLATE AND TRYING TO GET THE DRIVER TO ACHIEVE THE DESIRED TORQUE LEVEL. AFTER APPLYING ADDITIONAL FORCE, THE DRIVER HANDLE TORQUED OUT BUT IT WAS OBSERVED THAT THE TIP OF THE DRIVER SHAFT HAD SHEARED OFF INSIDE OF THE HEAD OF THE SCREW. THE SCRUB TECHNICIAN SWITCHED OUT THE U-JOINT SCREWDRIVER FOR THE STRAIGHT DRIVER SHAFT AND SURGEON INSERTED THE FOURTH AND FINAL SCREW WITH IT, BUT DID NOT FINAL-TIGHTEN IT, WHILE REP WENT DOWN TO SPD TO GRAB ANOTHER INSTRUMENT TRAY. THE BACK UP INSTRUMENT TRAY WAS OPENED BY THE CIRCULATING NURSE, THE WRAP INSPECTED FOR STERILITY AND CLEARED TO ENTER THE STERILE FIELD AND BACK TABLE. THE SCRUB TECHNICIAN ASSEMBLED THE TORQUE HANDLE AND U-JOINT SCREWDRIVER FROM THE SECOND INSTRUMENT TRAY AND THE FOURTH SCREW WAS FINAL-TIGHTENED WITHOUT ISSUE. THE AIMING GUIDE WAS REMOVED FROM THE IMPLANT A FEW DIFFERENT ATTEMPTS WERE MADE BY SURGEON TO REMOVE THE TIP OF THE BROKEN DRIV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21244487 ↗
• MalfunctionSep 3, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AUG 7, 2024, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT 3.0 N.M HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE DRAWING SPECIFICATION TORQUE TESTED LOW. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. ALL INFORMATION REGARDING THIS EVENT HAS BEEN REPORTED. THIS REPORT IS FOR ONE (1) TORQ LIMITING HANDLE - 4.5MM QK COUPLING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20130845 ↗
• MalfunctionAug 28, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING ROUTINE INCOMING INSPECTION OF A LOANER SET AT THE HOSPITAL, IT WAS OBSERVED THAT THE 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 ONE (1) 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 20091060 ↗
• MalfunctionAug 10, 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, WAS OBSERVED THAT MATERIAL, TORQ LIMITING HANDLE - 4.5MM QK COUPLING, WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 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 17500049 ↗
• MalfunctionJul 25, 2023Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON JULY 6, 2023, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET AT THE FACILITY, IT WAS OBSERVED THAT THE MATERIAL TORQ LIMITING HANDLE, 4.5MM QK COUPLING, SN J000338-14, WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE DRAWING SPECIFICATION IS 3.1 NM¿3.8 NM. THE TORQUE TESTED LOW ¿ 3.08 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) TORQ LIMITING HANDLE - 4.5MM QK COUPLING THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17391092 ↗
• MalfunctionJul 20, 2023Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6), 2023 DURING ROUTINE INCOMING INSPECTION OF A LOANER SET AT DISTRIBUTION CENTER (DC), IT WAS OBSERVED THAT MATERIAL TORQ LIMITING HANDLE - 4.5MM QK COUPLING, WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED LOW. THERE WAS NO KNOWN PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 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 17362937 ↗
• MalfunctionNov 23, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING EVALUATION ON AN UNKNOWN DATE, THE REPAIR TECHNICIANS FOUND THAT THE TORQ LIMITING HANDLE - 4.5MM QK COUPLING HAD FAILED IN CALIBRATION. ISSUE WAS FOUND DURING TESTING AT SERVICE & REPAIRS/MONUMENT. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 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 15851349 ↗
• MalfunctionNov 23, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING EVALUATION AT SERVICE AND REPAIR IT WAS FOUND OUT THAT THE TORQ LIMITING HANDLE - 4.5MM QK COUPLING FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE 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 15851294 ↗
• MalfunctionNov 7, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING EVALUATION THE REPAIR TECHNICIANS FOUND THAT THE TORQUE LIMITING HANDLE IN QUESTION HAD FAILED IN CALIBRATION. THE ISSUE WAS DISCOVERED DURING TESTING AT SERVICE & REPAIRS, MONUMENT. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 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 15743125 ↗
• MalfunctionOct 24, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING EVALUATION AT SERVICE AND REPAIR, IT WAS FOUND THAT THE TORQ LIMITING HANDLE - 4.5MM QK COUPLING HAD FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE 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 15659121 ↗
• MalfunctionOct 14, 2022Calibration Problem; Calibration Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15608961 ↗
• MalfunctionOct 14, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED ON (B)(6) 2022, DURING EVALUATION AT SERVICE AND REPAIR IT WAS FOUND OUT THAT THE TORQ LIMITING HANDLE - 4.5MM QK COUPLING HAD FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) TORQ LIMITING HANDLE - 4.5MM QK COUPLING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15607545 ↗
• MalfunctionSep 20, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED ON UNKNOWN DATE THAT , DURING EVALUATION AT SERVICE AND REPAIR IT WAS FOUND OUT THAT THE TORQUE LIMITING HANDLE QUICK COUPLING PART FAILED TORQUE TEST LOW. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR (1) TORQ LIMITING HANDLE: 4.5MM QK COUPLING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15453949 ↗
• MalfunctionAug 4, 2022Calibration Problem; Calibration Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15166619 ↗
• MalfunctionJul 22, 2022Calibration Problem; Calibration Problem

  THIS COMPLAINT INVOLVES ONE (1) DEVICE. IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TORQ LIMITING HANDLE DEVICE FAILED THE TEST. IT WA UNKNOWN IF IT OCCURRED DURING SURGERY OR IF THERE WAS PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) TORQ LIMITING HANDLE - 4.5MM QK COUPLING THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15088997 ↗
• MalfunctionJun 23, 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 FOUND THAT THE TORQUE-LIMITING HANDLE STRAIG W/RATCHET- DEVICE FAILED TORQUE TEST. THIS WAS FOUND DURING TESTING AT SERVICE AND REPAIR DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE TORQ LIMITING HANDLE - 4.5MM QK COUPLING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14787787 ↗
• MalfunctionJun 17, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING EVALUATION AT SERVICE AND REPAIR, THE TORQ LIMITING HANDLE - 4.5MM QK COUPLING WAS FOUND TO HAVE FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14732884 ↗
• 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 THE REPAIR TECHNICIANS FOUND THAT THE TORQ LIMITING HANDLE - 4.5MM QK COUPLING FAILED TORQUE TEST. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE(1) DEVICE TORQ LIMITING HANDLE - 4.5MM QK COUPLING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14645452 ↗
• MalfunctionJun 8, 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 TORQ LIMITING HANDLE - 4.5MM QK COUPLING FAILED TORQUE TEST. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE(1) DEVICE TORQ LIMITING HANDLE - 4.5MM QK COUPLING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14634266 ↗
• MalfunctionJun 8, 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 FOUND THAT PART FAILED THE TORQUE TEST. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE TORQ LIMITING HANDLE - 4.5MM QK COUPLING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14634224 ↗
• MalfunctionJun 8, 2022Calibration Problem; Calibration Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT TORQUE FAILED TEST. THIS COMPLAINT INVOLVES ONE (1) DEVICE TORQ LIMITING HANDLE - 4.5MM QK COUPLING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14633958 ↗
• MalfunctionMay 23, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING EVALUATION THE REPAIR TECHNICIANS FOUND THAT PART FAILED THE TORQUE TEST. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR A TORQUE LIMITING HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14474351 ↗
• MalfunctionMay 20, 2022Calibration Problem; Calibration Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT THE ON AN UNKNOWN DATE, DURING EVOLUTION THE REPAIR TECHNICIANS FOUND THAT THE TORQ LIMITING HANDLE - 4.5MM QK COUPLING PART FAILED TORQUE TEST. THERE WAS NO PATIENT AND PROCEDURE INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE TORQ LIMITING HANDLE - 4.5MM QK COUPLING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14463633 ↗
• MalfunctionMay 20, 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 A ROUTINE INCOMING INSPECTION IT WAS OBSERVED THAT TORQUE TEST FAIL. THERE WAS NO PATIENT AND HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICES TORQUE-LIMITING HANDLE STRAIGHT W/RATCHET-. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14463138 ↗
• MalfunctionMay 20, 2022Calibration Problem; Calibration Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT DURING EVALUATION THE REPAIR TECHNICIANS FOUND THAT PART FAILED TORQUE TEST. NO ADDITIONAL INFORMATION AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE TORQUE-LIMITING HANDLE STRAIGHT W/RATCHET-. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14463051 ↗