T-25 Standard Driver 1/4 Square XM-115-0025Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B064XM11500251), received between Jun 5, 2019 and Jun 5, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Damaged by Another Device” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2019Mechanical Problem; Device Damaged by Another Device; Mechanical Problem; Device Damaged by Another Device

  DURING SURGERY, THREE SCREW DRIVERS WERE BROKEN DURING THE FINAL TIGHTENING DURING PEDICLE SCREW SURGERY. THE BROKEN DRIVER TIPS REMAINED WITHIN THE SET SCREWS AND WERE RETRIEVED. SURGERY WAS DELAYED ONE HOUR TO REMOVE THE BROKEN DRIVER TIPS. THERE WAS NO INJURY TO THE PATIENT. ADDITIONAL CORRESPONDENCE WITH THE SALES REP IDENTIFIED THE FOLLOWING EVENTS: THE FIRST SCREW WAS SUCCESSFULLY TORQUED. WHEN TORQUING THE SECOND SCREW, THE SHAFT BROKE AT THE TOP OF THE CAP, FLUSH WITH THE SURFACE OF THE CAP BUT WITH MATERIAL LODGED INSIDE THE CAP. ANOTHER TWO SHAFTS BROKE WITH THE DEBRIS LODGED IN THE CAP. THE SALES REP WHO WAS AT THE SURGERY SUSPECTS THAT IT WAS THE TORQUE HANDLE THAT FAILED. PER THE SALES REP, THE TORQUE LIMITING DRIVER CLICKED ON THE FIRST SCREW BUT DID NOT CLICK WITH ANY OF THE ADDITIONAL SHAFTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8672592 ↗