NA 03.632.090Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034719313), received between Feb 28, 2017 and Mar 21, 2022 — 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.

• MalfunctionMar 21, 2022Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING AN INSPECTION IT WAS NOTICED THAT THE GREEN HANDLE LOOSENS ITSELF FROM THE RATCHET. NO SURGERY IMPACT. NO PATIENT IMPACT. THIS COMPLAINT INVOLVES ONE (1) DEVICE T-HANDLE W/RATCHET-WRENCH W/HEX-COUPL 6. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13839071 ↗
• MalfunctionFeb 28, 2017Break; Break

  IT IS REPORTED DURING A PROCEDURE TO REMOVE A MATRIX SPINE CONSTRUCT ON (B)(6) 2017, AFTER SUCCESSFULLY REMOVING TWO (2) MATRIX LOCKING CAPS, THE SURGEON ATTEMPTED TO REMOVE A LOCKING CAP AT L2 ON THE LEFT, USING A T-HANDLE T25 STARDRIVER SHAFT FOR MATRIX-LONG, BUT WAS NOT ABLE TO TURN THE LOCKING CAP. THIS ATTEMPT CAUSED THE STARDRIVER SHAFT TO BEND CLOSE TO THE DISTAL END OF THE INSTRUMENT. THE SURGEON THEN ATTEMPTED TO LOOSEN THE LOCKING CAP USING A RATCHET T-HANDLE WITH A T25 STARDRIVE SHAFT FOR MATRIX-LONG. THIS STARDRIVE SHAFT ALSO BECAME BENT. THE HANDLE SNAPPED AS INTERNAL COMPONENTS BROKE, RESULTING IN THE HANDLE SPINNING AROUND THE SHAFT AND NOT TURNING THE LOCKING CAP. ALTERNATE TECHNIQUES WERE ATTEMPTED WITHOUT SUCCESS. THE SURGEON THEN LOOSENED ALL REMAINING LOCKING CAPS WITH NO ISSUE. THE SURGEON THEN RETURNED TO THE LOCKING CAP THAT WOULD NOT RELEASE. IT WAS AT THAT TIME IT WAS NOTED THE SCREW BENEATH THE LOCKING CAP WAS LOOSE IN THE BONE. THE SURGEON WAS ABLE TO REMOVE THE SCREW AND ROD TOGETHER WITH THE LOCKING CAP USING GENERAL INSTRUMENTATION. IT IS NOT KNOWN IF THE SCREW WAS LOOSE PRIOR TO SURGERY OR IF IT BECAME LOOSE WHILE SURGEON WAS ATTEMPTING TO REMOVE THE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6366728 ↗