NA 394.40Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982199683), received between Nov 10, 2020 and Nov 10, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionNov 10, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2020, PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF RIGHT TIBIAL PLATEAU. DURING THE PROCEDURE THE NUT ON THE FEMORAL DISTRACTOR GOT STUCK IN THE MIDDLE OF THE BAR. IT GOT CROSS THREADED EITHER WHEN IT WAS BEING PUT INTO POSITION OR WHEN IT WAS BEING TAKEN OFF. DURING THE PROCEDURE THEY WERE NOT ABLE TO DISCONNECT IT; EVEN USING PLIERS. AFTER THE PROCEDURE, THE BOLT WAS ABLE TO BE REMOVED WITH SOME STRUGGLE. IT WAS NOTED WHEN THE DEVICE HAD BEEN ASSEMBLED BEFORE THE PROCEDURE, IT WAS A LITTLE STIFF, BUT IT WENT TOGETHER NICELY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY REPORTED. THIS REPORT IS FOR A THREADED SPINDLE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10817915 ↗