NA 394.42Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982199706), received between Nov 10, 2020 and Oct 10, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE PRODUCT 14.0MM THREADED SPINDLE 480MM (394.40) WAS STUCK & WOULD NOT MOVE WHEN CONNECTED TO THE PRODUCT SPINDLE NUT (394.42).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20418795 ↗
• MalfunctionMay 26, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THEY HAVE A SYNTHES THREADED ROD AND A WASHER SLEEVE THAT IS ATTACHED FIRMLY. THE OPERATING ROOM DEPT WAS NOT ABLE TO REMOVE THIS WASHER FROM THE ROD. THIS REPORT INVOLVES ONE (1) SPINDLE NUT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14517435 ↗
• MalfunctionNov 4, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, SIX (6) DEPTH GAUGES, ONE (1) SPINDLE NUT, ONE (1) WIRE SLEEVE, ONE (1) HANDLE FOR TORQUE LIMITING ATTACHMENT, AND ONE (1) UNIVERSAL CHUCK WERE BROKEN. THERE WAS NO PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) SPINDLE NUT. THIS IS REPORT 4 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12751952 ↗
• MalfunctionAug 31, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE UNIVERSAL CHUCK, SCREWDRIVER SHAFT, HAMMER GUIDE, STARDRIVE SCREWDRIVER SHAFT, CANNULATED HEXAGONAL SCREWDRIVER, THREADED ROD AND UNIVERSAL CHUCK WITH T-HANDLE ARE FOUND BROKEN DURING THE INSPECTION OUTSIDE THE SURGERY. PATIENT INVOLVEMENT IS UNKNOWN. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR (1) SPINDLE NUT. THIS REPORT IS 8 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12392797 ↗
• 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 SPINDLE NUT. THIS IS REPORT 2 OF 2 FOR (B)(4).

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

  MAUDE report 10817952 ↗