NA 03.130.005Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982075185), received between Apr 30, 2020 and Aug 25, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50436876 ↗
• MalfunctionJun 20, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE HANDLE PIECES ARE NOT STAYING TOGETHER. IT WILL EASILY DISASSEMBLE WITHOUT FORCE. SOMETHING INSIDE DEVICE IS NOT WORKING PROPERLY TO KEEP IT ASSEMBLED. NO PATIENT INVOLVEMENT WAS THERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22297260 ↗
• MalfunctionJun 7, 2025Break; Break

  IT WAS REPORTED THAT UPON ROUTINE INSPECTION, ITEM WAS FOUND BROKEN IN STERILE PROCESSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22163021 ↗
• MalfunctionSep 17, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON SEPTEMBER 5, 2024, DURING LOAN KIT INSPECTION IT WAS NOTICED THAT TWO (2) PIECES WERE STUCK TOGETHER UNABLE TO BE PULLED APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20238405 ↗
• MalfunctionJul 23, 2024Break; Break

  IT WAS REPORTED THAT ON JUNE 27, 2024 THE PRODUCT BROKE DURING SURGERY. IT DID NOT CAUSE ANY DELAY IN THE SURGERY. THIS REPORT INVOLVES ONE (1) HANDLE WITH HEX COUPLING. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19806416 ↗
• MalfunctionFeb 14, 2024Break; Break

  IT WAS REPORTED THAT ON FEBRUARY 1, 2024, THE DRIVER CAME APART. THERE WAS NO OPERATION INVOLVED. THIS REPORT INVOLVES ONE HANDLE WITH HEX COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18701843 ↗
• MalfunctionDec 29, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING POSTOPERATIVE INSPECTION OF THE SET, IT WAS NOTED THAT THE T6 SCREWDRIVER SHAFT WAS STUCK IN THE SCREWDRIVER HANDLE. THE DEVICE HAS BEEN THROUGH STERILE PROCESSING, BUT IT CANNOT BE COMPLETELY STERILIZED PER HOSPITAL STANDARDS BECAUSE THE SCREWDRIVER SHAFT IS STUCK IN THE HANDLE. THE LATCH MECHANISM ON THE SCREWDRIVER HANDLE IS STUCK AND IS NOT ALLOWING THE SCREWDRIVER SHAFT TO DISCONNECT WITH THE HANDLE. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR HANDLE WITH HEX COUPLING FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18419134 ↗
• MalfunctionNov 2, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE DEVICES IN QUESTION BROKE. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A HANDLE WITH HEX COUPLING. THIS IS REPORT 3 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18058895 ↗
• MalfunctionApr 14, 2023Mechanical Jam; Mechanical Jam

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON JANUARY 17, 2023, THE SCREWDRIVER SHAFT HAS SEIZED WITHIN THE SCREWDRIVER HANDLE. THIS WAS REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. IT WAS FOUND DURING PRODUCT INSPECTION ON APRIL 14, 2023 THAT THE RETURNED DEVICE COULD NOT BE FULLY DISASSEMBLED FROM THE SHAFT. AS A RESULT, THE SCREWDRIVER SHAFT WAS LEFT STUCK INTO THE LOCKING SLEEVE. THIS REPORT INVOLVES ONE HANDLE WITH HEX COUPLING. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16745652 ↗
• MalfunctionJan 11, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE REPORTED PRODUCTS WERE BROKEN/DAMAGED. NO PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT IS FOR ONE (1)HANDLE WITH HEX COUPLING. THIS IS REPORT 2 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16137110 ↗
• MalfunctionApr 30, 2020Break; Break

  CONCOMITANT DEVICES REPORTED: TORQUE LIMITER, 0.8 NM, WITH AO/ASIF QUICK COUPLING, DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS, HANDLE WITH HEX COUPLING.

  Patient problems: No Patient Involvement

  MAUDE report 10015972 ↗