NA 314.20Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982188670), received between Nov 14, 2018 and Jan 30, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026Contamination /Decontamination Problem

  IT WAS REPORTED MULTIPLE COMPOSITE HANDLE TRAUMA PRODUCTS ARE LEAKING CAUSING STERILITY ISSUES. NO PATIENT HARM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223171 ↗
• MalfunctionFeb 15, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DRIVERS (314.20) FROM TWO DIFFERENT SETS OF 4.5MM CANNULATED SCREWS ARE WORN AND ROUNDED. THERE WAS NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) CANNULATED 3.5MM HEXAGONAL SCREWDRIVER THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18711442 ↗
• MalfunctionFeb 15, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DRIVERS (314.20) FROM TWO DIFFERENT SETS OF 4.5MM CANNULATED SCREWS ARE WORN AND ROUNDED. THERE WAS NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) CANNULATED 3.5MM HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18711401 ↗
• MalfunctionAug 6, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE, THE SCREWDRIVERS LEFT A STAIN IN THE PEEL PACK AFTER STERILIZATION. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) CANNULATED 3.5MM HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8864741 ↗
• MalfunctionNov 14, 2018Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN HARDWARE REMOVAL, A CANNULATED HEXAGONAL SCREWDRIVER BROKE OUTSIDE THE PATIENT AND THE FRAGMENTS WERE RECOVERED. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY REPORTED. PATIENT OUTCOME IS STABLE. THIS REPORT IS FOR ONE (1) CANNULATED 3.5MM HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8072089 ↗