NA 314.13Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982188571), received between Mar 24, 2017 and Nov 13, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Integrity 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.

• MalfunctionNov 13, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED VIA FEEDBACK FROM OR STAFF THAT THE T8 DRIVER REQUIRED REPLACING DUE TO DIFFICULTY ENGAGING WITH SCREW HEADS. IT WAS ALSO REPORTED THAT OTHER ITEMS NEEDED TO BE INSPECTED DURING THE SALES REP VISIT. AFTER INSPECTION FROM THE SALES REP WAS COMPLETED, OTHER ITEMS WERE FOUND REQUIRING REPLACEMENT DUE TO THEIR BEING WORN. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A LARGE HEXAGONAL SCREWDRIVER WITH T-HANDLE. THIS IS REPORT 3 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18123083 ↗
• MalfunctionJun 23, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, UPON INSPECTING SOME INSTRUMENTS IN THE STERILE PROCESSING, IT WAS NOTICED THAT TWO (2) SCREWDRIVERS WERE DAMAGED. THERE WAS NO KNOWN PATIENT INVOLVEMENT. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE ON (B)(6) 2021 IT WAS IDENTIFIED THAT THE DISTAL TIP OF THE SCREWDRIVER WAS TWISTED. THIS REPORT IS FOR ONE (1) LARGE HEXAGONAL SCREWDRIVER WITH T-HANDLE THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12054218 ↗
• MalfunctionJun 23, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, UPON INSPECTING SOME INSTRUMENTS IN THE STERILE PROCESSING, IT WAS NOTICED THAT TWO (2) SCREWDRIVERS WERE DAMAGED. THERE WAS NO KNOWN PATIENT INVOLVEMENT. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE ON JUNE 16, 2021 IT WAS IDENTIFIED THAT THE DISTAL TIP OF THE SCREWDRIVER WAS TWISTED. THIS REPORT IS FOR ONE (1) LARGE HEXAGONAL SCREWDRIVER WITH T-HANDLE THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12054196 ↗
• MalfunctionFeb 22, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING ROUTINE INSPECTION OF THE SCREW REMOVAL SET, A CONICAL EXTRACTION SCREW HAD STRIPPED THREADS, CRUCIFORM SCREWDRIVER SHAFT HAD A DAMAGED CRUCIFORM TIP, A LARGE HEXAGONAL SCREWDRIVER WITH T-HANDLE HAD WORN/ROUNDED HEX FLATS, AND A 2.4MM STARDRIVE SCREWDRIVER SHAFT HAD THE TEETH WORN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) LARGE HEXAGONAL SCREWDRIVER WITH T-HANDLE. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8362331 ↗
• MalfunctionMar 24, 2017Bent; Material Distortion; Bent; Material Distortion

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SALES CONSULTANT WAS VIEWING THE INSTRUMENT SET AND NOTICED THAT THE TIP OF THE HEXAGONAL SCREWDRIVER WITH T-HANDLE WAS TWISTED. THE SCREWDRIVER WAS NOT NEEDED FOR THE PROCEDURE AND HAD NO BEARING ON THE OUTCOME OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN AS TO WHEN THE TIP BECAME DAMAGED. THE TIP IS TWISTED AND DOES NOT APPEAR TO BE BROKEN. THIS COMPLAINT INVOLVES ONE DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6434369 ↗