NA 03.620.001Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034717418), received between Jul 21, 2017 and Jan 13, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Compatibility Problem

  DURING A SCREW REMOVAL CASE, THE T25 T-HANDLE SCREWDRIVER FROM THE SPINE REMOVAL SET DISENGAGED FROM THE SCREWDRIVER SHAFT. THE FIXED T-HANDLE DISASSOCIATED FROM THE SCREWDRIVER SHAFT AND THE INSTRUMENT IS NO LONGER USABLE. A SECOND T25 SCREWDRIVER WAS USED TO COMPLETE THE SCREW REMOVAL WITH NO DELAY. NO FRAGMENTS WERE GENERATED AND NO MEDICAL INTERVENTION OR SURGICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059922 ↗
• MalfunctionDec 16, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED ON (B)(6) 2022, THAT DURING SURGERY, THE SURGEON WAS ATTEMPTING TO REMOVE THE SET CAP FROM A PREVIOUS FUSION, THE TIP OF THE SCREW DRIVER BROKE OFF INTO THE SET CAP. THE SCREW/ROD/SET CAP WAS ABLE TO BE REMOVED NO PIECES WERE REMAINING IN THE PATIENT. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER T25 WITH T-HANDLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15999870 ↗
• InjuryJan 3, 2019Device Slipped; Device Slipped

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A UNIVERSAL REDUCTION SCREW (URS) WITHDRAWAL SURGERY DUE TO UNKNOWN REASONS. ONCE IN THE OPERATING ROOM, TWO (2) SCREWDRIVER SHAFTS STARDRIVE T25, FOR URS WERE DISCOVERED TO BE BROKEN. THE SURGEON DECIDED TO USE THE SCREWDRIVER STARDRIVE T25 WITH T-HANDLE FOR PANGEA INSTEAD. HOWEVER, THE HANDLE OF THE STEM LOOSENED WHILE IN USE. EVEN THOUGH BOTH ENDS OF THE TWO (2) SCREWDRIVER SHAFTS STARDRIVE T25 FOR URS WERE BROKEN, THE SURGEON TRIED TO USE THEM, AND THEY RELEASED PIECES OF METAL INTO THE PATIENT'S CAVITY. ALL FRAGMENTS WERE REMOVED FROM THE CAVITY. THE SURGERY WAS COMPLETED WITH THE USE OF PRESSURE PLIERS SUCH AS CABLE OF THE SCREWDRIVER STARDRIVE T25 WITH T-HANDLE FOR PANGEA. THERE WAS A 15 MINUTES SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES: SPINE SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A STARDRIVE SCREWDRIVER T25 WITH T-HANDLE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8212270 ↗
• InjuryJul 21, 2017Detachment Of Device Component; Detachment Of Device Component

  STRAIGHT BAR IS THE 6.0MM ROD IMPLANTED IN PATIENT ON (B)(6) 2017. CONCOMITANT DEVICE REPORTED: ROD (498.151, LOT NUMBER UNKNOWN, QUANTITY 1).

  Patient problems: No Code Available

  MAUDE report 6733510 ↗