NA 314.80Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982189103), received between Feb 25, 2019 and May 12, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, SCREWDRIVERS WERE STRIPPED. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THIS COMPLAINT INVOLVES NINE (9) DEVICES. THIS REPORT IS FOR ONE (1) CANNULATED 3.5 HEXAGONAL SCREWDRIVER SFT. THIS IS REPORT 8 OF 9 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16923565 ↗
• MalfunctionFeb 12, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN UNKNOWN SURGERY PROCEDURE WAS PERFORMED. DURING THE PROCEDURE, FOUR (4) HEXAGONAL SCREWDRIVER SHAFTS WERE STRIPPED, ONE (1) ELITE IMPRESSION IMPLANT KIT WAS BROKEN, ONE (1) COMPRESSION WIRE WAS BROKEN, AND THREE (3) NON-THREADED GUIDEWIRE WERE BROKEN. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THE PROCEDURE OUTCOME IS UNKNOWN. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) CANNULATED 3.5MM HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 9 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11320060 ↗
• MalfunctionFeb 11, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN UNKNOWN SURGERY PROCEDURE WAS PERFORMED. DURING THE PROCEDURE, FOUR (4) HEXAGONAL SCREWDRIVER SHAFTS WERE STRIPPED, ONE (1) ELITE IMPRESSION IMPLANT KIT WAS BROKEN, ONE (1) COMPRESSION WIRE WAS BROKEN, AND THREE (3) NON-THREADED GUIDEWIRE WERE BROKEN. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THE PROCEDURE OUTCOME IS UNKNOWN. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) CANNULATED 3.5MM HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 2 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11319076 ↗
• MalfunctionFeb 25, 2019Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL OF ALL SCREWS. DURING THE PROCEDURE, THE CANNULATED HEXAGONAL SCREWDRIVER SHAFT BROKE AND WAS UNABLE TO BE RELEASED FROM THE HANDLE WITH QUICK COUPLING. TWO (2) T-HANDLES WITH QUICK COUPLING WERE BOTH STUCK ON THE EXTRACTION DEVICES, CONICAL EXTRACTION SCREW FOR LARGE SCREWS AND CONICAL EXTRACTION SCREW FOR CORTEX SCREWS AND ARE NOW PERMANENTLY LOCKED IN. CANNULATED HEXAGONAL SCREWDRIVER WAS STUCK ON THE 3RD HANDLE WITH QUICK CONNECT. THREE QUICK CONNECT HANDLES ABOVE BECAME JAMMED ON THREE ITEMS, THE EXTRACTION DEVICES AND THE CANNULATED EXTRA DRIVER SHAFT. ALL PIECES WERE RETRIEVED AND REMOVE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WAS GOOD. THIS REPORT IS FOR ONE (1) CANNULATED 3.5MM HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8366408 ↗