NA 397.705Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982201065), received between Oct 26, 2018 and May 29, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2025Break; Break

  IT WAS REPORTED THAT DURING SURGERY, WHILE PLACING THE LOCKING SCREWS, THE SPECIALIST WAS APPLYING TORQUE TO THE LAST SCREW PLACED, AND AT THAT MOMENT THE TORQUE ADAPTER HANDLE BROKE. THEREFORE, THERE WAS NO NEED TO PROVIDE A SOLUTION TO THE PROBLEM SINCE THIS OCCURRED WITH THE LAST SCREW, AND THE FRAGMENTS OF THIS HANDLE WERE REMOVED. DUE TO THIS DAMAGE, THE SPECIALIST DID NOT EXPERIENCE ANY DISCOMFORT; THE SURGERY WAS COMPLETED SUCCESSFULLY, WITHOUT ANY HARM TO THE PATIENT OR ALTERATIONS IN SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22106233 ↗
• MalfunctionJan 29, 2024Break; Break

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT DURING THE LOCAL/INTERNAL INSPECTION IN THE ORTHO KIT LOANER DEPARTMENT THE FOLLOWING PRODUCT DEVIATION WAS IDENTIFIED: THE MATERIAL ON THE SILICONE HANDLE WAS PEELING OFF. THERE WAS NO PATIENT IMPACT. THERE WAS NO SURGICAL DELAY THIS REPORT IS FOR ONE (1) HAND F/TORQUE LIMITER NO. 511.774 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18596650 ↗
• MalfunctionMay 24, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED, THAT ON AN UNKNOWN DATE. THE 1.5 NM TORQUE LIMITER THAT FORMS PART OF THE SCREWDRIVER SETUP WAS BROKEN. THE SURGEON HAS, HAD TO TIGHTEN THE SCREWS BY HAND USING ESTIMATED PRESSURE WHICH GOES AGAINST THE MANDATORY REQUIREMENTS OF THE SYSTEM AS PER THE SURGICAL TECHNIQUE. THIS REPORT INVOLVES ONE (1) HANDLE QC FOR COMPACT AIR DRIVE. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS PRODUCT COMPLAINT; (B)(4), CAPTURES A PREVIOUS TIME, THAT THE DEVICE BROKE. AND IS RELATED TO (B)(4), CAPTURES THE DEVICE BREAKING ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16991336 ↗
• MalfunctionMay 15, 2023Break; Break

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE TORQUE LIMITER IN QUESTION FROM THE LOAN KIT WAS FOUND TO BE BROKEN. THERE WAS NO REPORTED PATIENT INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A HANDLE QC FOR COMPACT AIR DRIVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16929556 ↗
• MalfunctionMay 11, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, A 1.5 NM TORQUE LIMITER THAT FORMS PART OF THE SCREWDRIVER SETUP WAS BROKEN ON THE LOAN SET. WITH THE TORQUE LIMITER BROKEN, THE SURGEON HAD TO TIGHTEN SCREWS BY HAND USING ESTIMATED PRESSURE, WHICH HAS IMPLICATIONS FOR THE STRENGTH AND INTEGRITY OF THE CONSTRUCT AND IS ESPECIALLY IMPORTANT SINCE THE PLATE WAS ON A WEIGHT BEARING BONE. THIS REPORT INVOLVES ONE HANDLE QC FOR COMPACT AIR DRIVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16911867 ↗
• MalfunctionMay 21, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, THE NON-ACCEPTANCE OF THE INSTRUMENT WITH CABLE IN CELERON MATERIAL BY (B)(6), WE CONSULTED WITH NURSE (B)(6), RESPONSIBLE FOR THE TECHNICAL AREA OF THE HOSPITAL'S MATERIALS CENTER. IT IS A MATERIAL THAT HAS POROSITY DUE TO EXPOSURE TO THE TEMPERATURE OF THE STERILIZATION PROCESS. IT IS THE POROSITY OF THE CELERON THAT COMPROMISES THE CLEANING PROCESS. IT WAS UNDERSTOOD THEN THAT THE MATERIAL COMPROMISES THE STERILIZATION PROCESS, SINCE IT HAS POROSITY THAT DOES NOT GUARANTEE THE EFFECTIVENESS OF CLEANING. IF YOU ARE NOT IN ACCORDANCE WITH THE JUSTIFICATION PRESENTED, I SUGGEST THAT YOU PRESENT TO THE HOSPITAL TECHNICIANS RESPONSIBLE, A DOCUMENT WITH THE MANUFACTURER'S SPECIFICATIONS THAT MEET THE STANDARDS OF THE MANUALS OF GOOD CLEANING AND STERILIZATION PRACTICES. THIS REPORT IS FOR ONE (1) HANDLE QC FOR COMPACT AIR DRIVE. THIS IS REPORT 2 OF 15 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11862810 ↗
• MalfunctionOct 28, 2020Device Reprocessing Problem; Device Reprocessing Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HANDLE COULD NOT BE CLEANED AND DISINFECTED AT THE HOSPITAL BECAUSE IT DISINTEGRATED OVER TIME. NO SURGICAL INVOLVEMENT. NO PATIENT IMPACTED. THIS REPORT IS FOR ONE (1) HANDLE QC FOR COMPACT AIR DRIVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10750189 ↗
• MalfunctionOct 26, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING WASHING AND STERILIZATION OF INSTRUMENTS ON AN UNKNOWN DATE, THE STARDRIVE SCREWDRIVER, HANDLE FOR TORQUE LIMITER, AND SCREWDRIVER HEXAGONAL LARGE WERE NOTICED OF RELEASING A RUST LIKE LIQUID AND WAS OBSERVED OF STAINING THE FIELDS. IT IS UNKNOWN IF THERE WERE PATIENT AND SURGICAL PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) HANDLE FOR TORQUE LIMITER. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8010280 ↗