NA 03.620.002Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034717425), received between Dec 12, 2016 and Oct 24, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Bent” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2017Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE STARDRIVE SCREWDRIVER SHAFT WAS STRIPPED DURING AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) PROCEDURE ON (B)(6) 2017. ANOTHER SCREWDRIVER SHAFT FROM THE SET WAS USED TO COMPLETE THE SURGERY WITH NO DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH GREAT PATIENT OUTCOME.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 6973992 ↗
• MalfunctionDec 12, 2016Bent; Material Distortion; Bent; Material Distortion

  IT WAS REPORTED THAT IN THE STERILE PROCESSING ROOM, ONE (1) STARDRIVE SCREWDRIVER SHAFT T25/6MM HXC AND ONE (1) STARDRIVE SCREWDRIVER SHAFT T25/6MM HXC-LONG DEVICES WERE BOTH DISCOVERED TO BE BENT UP AND TWISTED DUE TO OVERUSE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT T25/6MM HXC-LONG. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6168677 ↗