NA 698343665Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034535043), received between Nov 14, 2019 and Nov 18, 2019 — classified as 2 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 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.

• MalfunctionNov 18, 2019Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR LUMBAR INTERBODY FUSION ON AN UNKNOWN DATE, A SCREW WOULD NOT ADVANCE, AND THE SCREWDRIVER WAS DETERMINED TO BE BROKEN. IT IS POSSIBLE THERE WAS OVER TORQUEING SINCE THE TORQUE LIMITING DEVICE WAS NOT USED, BUT THERE WAS NOT A SPECIFIC POINT TO DETERMINE WHEN THE DRIVER BROKE. STAR DRIVE OF SCREWDRIVER SPINS WHEN ATTEMPTING TO ADVANCE SCREW. THUS, A HANDLE WITH QUICK COUPLING WAS USED WITH AN UNKNOWN SCREWDRIVER SHAFT. THERE WERE TEN (10) TO FIFTEEN (15) MINUTES DELAY. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCES. CONCOMITANT DEVICES: SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A SYNFIX EVO DRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9334485 ↗
• MalfunctionNov 14, 2019Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR SPINE FUSION ON AN UNKNOWN DATE, THE SCREWDRIVER WAS BROKEN; AN UNKNOWN SCREW JUST SPINNING. THERE WERE NO FRAGMENTS GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF TEN (10) - FIFTEEN (15) MINUTES. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES: SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A SYNFIX EVO DRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9323736 ↗