NA U44-642-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705034711102), received between Sep 14, 2017 and Nov 6, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THE INSTRUMENTS BROKE FROM NORMAL USAGE OVER TIME. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23489848 ↗
• MalfunctionNov 6, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THE INSTRUMENTS BROKE FROM NORMAL USAGE OVER TIME. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23489836 ↗
• MalfunctionNov 6, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THE INSTRUMENTS BROKE FROM NORMAL USAGE OVER TIME. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23489830 ↗
• MalfunctionNov 6, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THE INSTRUMENTS BROKE FROM NORMAL USAGE OVER TIME. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23489806 ↗
• MalfunctionFeb 28, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED ON AN UNKNOWN DATE, THE INSTRUMENT WAS BROKEN. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1)SCREWDRIVER FOR PINS THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18803510 ↗
• MalfunctionFeb 28, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED ON AN UNKNOWN DATE, THE INSTRUMENT WAS BROKEN. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1)SCREWDRIVER FOR PINS THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18803484 ↗
• MalfunctionFeb 28, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED ON AN UNKNOWN DATE, THE INSTRUMENT WAS BROKEN. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) SCREWDRIVER FOR PINS, THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18803466 ↗
• MalfunctionApr 5, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENT DID NOT FUNCTION PROPERLY. THERE WAS NO SURGICAL DELAY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SCREWDRIVER FOR PINS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16681223 ↗
• MalfunctionMay 20, 2020Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE PIN HOLDER WAS FOUND TO BE BROKEN. A LEVER WAS BROKEN OFF, AND IT COULD NOT HOLD PINS. THIS REPORT INVOLVES ONE (1) SCREWDRIVER FOR PINS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10074611 ↗
• MalfunctionSep 14, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AFTER STERILIZATION OF THE ANTERIOR CERVICAL FUSION TRAY, THE BOTTOM OF THE PAN HAD A BROWN RESIDUE POOLED AT THE BOTTOM. THIS MADE THE TRAY CONTAMINATED AND UNUSABLE IN SURGERY. A SWAB TEST WAS DONE BY THE HEAD OF THE STERILIZATION DEPARTMENT. THE TEST CAME BACK WITH NO TRACES OF BIOLOGIC MATERIALS. THEREFORE, THE CONTAMINATING SUBSTANCE MOST LIKELY CAME FROM THE SYNTHES TRAY. NO PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) SCREWDRIVER FOR PINS. (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6864430 ↗