NA 388.032Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034771731), received between Mar 27, 2018 and Jan 21, 2020 — classified as 2 malfunctions.

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

• MalfunctionJan 21, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN UNKNOWN SURGERY ONE (1) STARDRIVE SCREW DRIVER SNAPPED IN THE SHAFT AND THE HEAD OF ONE (1) STARDRIVE SCREWDRIVER WOULD NOT HOLD THE SCREW. THERE WAS NO REPORTED SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS REPORT IS FOR ONE 3.5MM/4.0MM STARDRIVE(TM) SCREWDRIVER SELF-RETAINING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9613080 ↗
• MalfunctionMar 27, 2018Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT STARDRIVE SCREWDRIVERS WERE FOUND DURING STERILE PROCESSING TO BE DAMAGED. IT WAS FURTHER EXPLAINED THAT THE SHAFT OF THE DEVICES HAD TIPS THAT WERE TWISTED AND WARPED AS THOUGH THEY HAD BEEN INADVERTENTLY USED TO OVERTIGHTEN SCREWS. IT WAS CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT AND THAT THE DEVICE MALFUNCTIONS HAD NO IMPACT ON ANY SURGICAL PROCEDURE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7373443 ↗