NA 388.652Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034773681), received between Aug 22, 2024 and Jun 30, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJun 30, 2025Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON ATTACHED THE INSTRUMENT TO A SWIZZLE STICK, AND WAS UNABLE TO RATCHET THE SCREW IN. THERE WAS NO GENERATION OF FRAGMENTS. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22365392 ↗
• MalfunctionAug 22, 2024Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, WHILE THE SURGEON WAS PLACING THE ILIAC SCREWS FOR USS HE CHANGED AND STARTED USING THE RATCHET HANDLE. AFTER A WHILE THE HANDLE WAS NOT RATCHETING AND STOPPED WORKING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. NO PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT INVOLVES ONE (1) RATCHET T-HANDLE 6MM HXC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20043122 ↗