NA 03.110.005Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 10886982071835), received between Aug 13, 2018 and Sep 24, 2026 — classified as 70 malfunctions.

The most frequently reported specific device problem is “Break” (43 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 70 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890525 ↗
• MalfunctionApr 28, 2026Break

  IT WAS REPORTED THAT HANDLE F/TORQUE LIMITERS 0.4/0.8/1.2NM AND 2.0/2.4MM DEPTH GAUGE 50MM WERE REPORTED TO HAVE FAILED DURING USE. THE TORQUE LIMITING HANDLE'S INNER PORTION WAS NO LONGER RETAINED, CAUSING IT TO SLIDE OUT AND RENDERING THE HANDLE NONFUNCTIONAL. THE DEPTH GAUGE WAS BROKEN AT THE HOOKED TIP, MAKING IT UNUSABLE. THERE WAS NO REPORTED PATIENT HARM OR SIGNIFICANT DELAY ASSOCIATED WITH THESE FAILURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25016316 ↗
• MalfunctionApr 7, 2026Device-Device Incompatibility

  DURING REPROCESSING, STAFF NOTICED THAT THE TORQUE LIMITER AND HANDLE WERE STUCK TOGETHER. THE SALES REPRESENTATIVE TRIED DISASSEMBLING THEM, BUT WAS UNABLE TO DO SO. THERE ARE NO CRACKS OR DAMAGED PIECES. SOMETHING WITH THE INTERNAL COUPLING MECHANISM IS BROKEN. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24802963 ↗
• MalfunctionJan 16, 2026Break

  HANDLE, TORQUE-LIMITING AND THE ATTACHMENT, TORQUE LIMITING 1.2NM ARE BROKEN. THE TORQUE LIMITING ATTACHMENT WILL NOT COME OUT OF THE HANDLE. THERE WAS NO PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24098597 ↗
• MalfunctionNov 19, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TORQUE LIMITING ATTACHMENT WOULD NOT SECURELY ATTACH TO THE HANDLE. THE ISSUE WITH THE HANDLE WAS DISCOVERED PRE-OP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23596259 ↗
• MalfunctionSep 19, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE, THE TORQUE LIMITER WAS STUCK TO THE HANDLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23094475 ↗
• MalfunctionJul 23, 2025Use of Device Problem; Device-Device Incompatibility; Use of Device Problem; Device-Device Incompatibility

  IT WAS REPORTED DURING THE PROCEDURE, AT THE TIME OF MOUNTING THE SCREWS, IT IS EVIDENT THAT THE SCREWDRIVERS ARE ROLLED SO IT MAKES IT DIFFICULT TO MOUNT THEM. WHEN LOCKING THE SCREWS, THE HANDLE WHERE THE DYNAMOMETRIC IS INSERTED DOES NOT PRESENT THE SIDE LOCKING SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22574595 ↗
• MalfunctionJul 7, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PREOPERATIVELY, TLA AND HANDLE ATTACHMENT STUCK TOGETHER. UNABLE TO BE SEPARATED WITHOUT DAMAGING BOTH PARTS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22416396 ↗
• MalfunctionMay 1, 2025Break; Break

  IT WAS REPORTED THAT THERE WERE BROKEN DEPTH GAUGES IN SPD AND HANDLE. THIS EVENT HAPPENED DURING STERILE PROCESSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21945349 ↗
• MalfunctionJan 2, 2025Break; Break

  IT WAS REPORTED THAT ON DECEMBER 16, 2024, A HANDLE WAS BROKEN. IT LOOKED LIKE THE BREAK WAS THROUGH USAGE.

  Patient problems: Insufficient Information

  MAUDE report 21055130 ↗
• MalfunctionNov 27, 2024Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE THE SCREWDRIVER IS MISSING LITTLE SCREW. UNABLE TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798528 ↗
• MalfunctionNov 18, 2024Break; Break

  IT WAS REPORTED, THAT THE HANDLE FOR TORQUE LIMITING ATTACHMENT BROKE, DURING THE CASE. THE METAL TORQUE LIMITER INSIDE THE BLUE HANDLE CAME APART. AND WE WERE UNABLE TO USE THE HANDLE. THE CASE WAS COMPLETED WITHOUT INCIDENT, BECAUSE WE USED A DIFFERENT HANDLE. THERE WAS NO SURGICAL DELAY. PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20708653 ↗
• MalfunctionOct 23, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024 THE HANDLE FOR THE TORQUE BROKE INTO TWO PIECES. THERE WAS NO PATIENT AND OPERATION INVOLVED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20518288 ↗
• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE SCREWDRIVER HAD A FAULTY BLACK HANDLE & TORQUE LIMITER. THIS REPORT INVOLVES ONE (1) HANDLE FOR TORQUE LIMITING ATTACHMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20039316 ↗
• MalfunctionJul 9, 2024Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE ITEM WAS MISSING THE SCREW. THIS WAS IDENTIFIED DURING LOAN KIT INSPECTION BY THE LOAN KIT TECHNICIAN. NO FURTHER DETAILS ARE AVAILABLE. THIS REPORT INVOLVES ONE HANDLE FOR TORQUE LIMITING ATTACHMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19704787 ↗
• MalfunctionMay 10, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PIECE OF THE INSTRUMENTS WERE MISSING, THEY WERE NOT FUNCTIONAL. THERE WAS NO PATIENT CONSEQUENCES. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE HANDLE FOR TORQUE LIMITING ATTACHMENT THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19291179 ↗
• MalfunctionJan 31, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE SALES REP HAD BROKEN INSTRUMENTS. THE SALES REP WAS TRYING TO EXCHANGE ON WARRANTY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) HANDLE FOR TORQUE LIMITING ATTACHMENT THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18618688 ↗
• MalfunctionJan 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON JANUARY 9, 2023, THE PATIENT UNDERWENT THE ORIF FOR THE LEFT OLECRANON FRACTURE. DURING PLATE FIXATION, ALL INSERTED LOCKING SCREWS COULD NOT BE FULLY TIGHTENED. THE NUMBER OF INSERTED SCREWS IS UNKNOWN. ALTHOUGH THE SURGEON ASSEMBLED THE SCREWDRIVER SHAFT, THE TORQUE LIMITER, AND THE HANDLE FOR TIGHTENING SCREWS, THE SCREWS COULD NOT BE FULLY TIGHTENED. THEREFORE, THE SURGEON TIGHTENED THE SCREWS WITH THE SAME FEELING AS WHEN THE SURGEON ALWAYS DID. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) HANDLE F/TORQUE LIMITERS 0.4/0.8/1.2NM THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18580355 ↗
• MalfunctionDec 8, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICE WAS FOUND STUCK TOGETHER WITH THE HANDLE, AND THE TORQUE LIMITER WOULD NOT COME APART. THERE WERE NO PATIENT CONSEQUENCES. THE ISSUE WAS FOUND POSTOPERATIVELY. THIS REPORT INVOLVES ONE HANDLE FOR TORQUE LIMITING ATTACHMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18290297 ↗
• MalfunctionDec 4, 2023Device-Device Incompatibility; Device-Device Incompatibility

  THE INITIAL COMPLAINT WAS REVIEWED, AND THE HANDLE FOR TORQUE LIMITING ATTACHMENT WAS DETERMINED TO BE NOT REPORTABLE, AS IT IS A DUPLICATE OF ANOTHER COMPLAINT. THE INVOLVED HANDLE FOR TORQUE LIMITING ATTACHMENT WAS REPORTED IN MANUFACTURER REPORT NUMBER 8030965-2023-15492.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18256612 ↗
• MalfunctionOct 12, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREWDRIVER HANDLE BROKE AT THE HOSPITAL. THE CASE WAS ABLE TO STILL GO AHEAD AS WE WERE ABLE TO SOURCE ANOTHER HANDLE. THE PATIENT WAS NOT AFFECTED. THIS REPORT INVOLVES ONE (1) HANDLE FOR TORQUE LIMITING ATTACHMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17919602 ↗
• MalfunctionAug 14, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHILE CLEANING THE INSTRUMENTS AND SETS, IT WAS NOTICED THAT SOME INSTRUMENTS AND MODULES WERE BROKEN. THERE WERE NO PATIENT CONSEQUENCES/OUTCOME. THIS REPORT IS FOR HANDLE FOR TORQUE LIMITING ATTACHMENT FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17540445 ↗
• MalfunctionJul 3, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE TLA NOT FITTING ONTO TORQUE LIMITING HANDLE. BUTTING WAS BROKEN. NO PATIENT INVOLVEMENT WAS THERE. THIS REPORT IS FOR ONE (1) HANDLE FOR TORQUE LIMITING ATTACHMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17246404 ↗
• MalfunctionJun 7, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A LIST OF BROKEN ITEMS COLLECTED FROM THE SPD OF ACCOUNTS IN T241. ALL ITEMS WERE DISCOVERED BROKEN AT POST-OP AND DID NOT EFFECT SURGICAL CAPABILITIES. REPLACEMENT NEEDED. THIS REPORT IS FOR ONE (1) HANDLE FOR TORQUE LIMITING ATTACHMENT. THIS IS REPORT 8 OF 12 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17078779 ↗
• MalfunctionJun 7, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A LIST OF BROKEN ITEMS COLLECTED FROM THE SPD OF ACCOUNTS IN T241. ALL ITEMS WERE DISCOVERED BROKEN AT POST-OP AND DID NOT EFFECT SURGICAL CAPABILITIES. REPLACEMENT NEEDED. THIS REPORT IS FOR ONE (1) HANDLE FOR TORQUE LIMITING ATTACHMENT. THIS IS REPORT 7 OF 12 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17078776 ↗