NA 03.231.015Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982077431), received between Mar 11, 2022 and Sep 28, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 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.

• MalfunctionSep 28, 2026Material Twisted/Bent

  It was reported that the T25 screwdriver was not gripping screw. There was no patient harm or surgical delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918846 ↗
• MalfunctionJul 8, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENTS WERE BROKEN. IT IS UNKNOWN IF THERE WAS PATIENT OR PROCEDURE INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SD25 STARDRIVE SCRWDRVR SHAFT WITH 6MM HEX COUPLING/180MM. THIS IS REPORT 3 OF 8 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED IN (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19694278 ↗
• MalfunctionFeb 3, 2023Crack; Contamination /Decontamination Problem; Device-Device Incompatibility; Scratched Material; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE DEVICES WERE UNABLE TO USE OR STERILIZE AND ASSEMBLE, BECAUSE THE OF CHIPPING AND CRACKING. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR ONE (1) SD25 SD SCRWDRVR SFT 6 HEX COUPLING/180. THIS IS REPORT 1 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16300342 ↗
• MalfunctionDec 9, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON NOVEMBER 17 2022, THE SCREWDRIVER THAT IS PART OF THE VA LARGE FRAGMENT TRAY HAD BEEN DAMAGED AND NEEDED REPLACEMENT. ONE OF THE POINTS ON THE STARDRIVE DESIGN HAD BROKEN OFF MEANING IT WOULD NOT ENGAGE PROPERLY IN A RECESS. THERE WAS NO EVIDENCE OF POOR USE OR EXCESSIVE PRESSURE WHEN IN A SCREW. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SD25 STARDRIVE SCRWDRVR SHAFT WITH 6MM HEX COUPLING/180MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15954169 ↗
• MalfunctionMar 11, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE SCREWDRIVER SHAFT WAS DISCOVERED TO HAVE A ROUNDED TIP. THERE WAS NO PATIENT INVOLVEMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE USE OF ANOTHER INSTRUMENT FROM ANOTHER SET. THIS REPORT IS FOR ONE (1) SCREWDRIVER THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13736816 ↗