NA 1895-5075SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540202185), received between Jun 29, 2020 and Dec 10, 2025 — classified as 1 injury, 3 malfunctions.

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

• InjuryDec 10, 2025Fracture; Fracture

  AS REPORTED: "BOLTS BROKE IN PATIENT LEG REVISION WAS NEEDED, THE SURGEON HAD TO DO ANOTHER SURGERY."

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 23772270 ↗
• MalfunctionSep 23, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT AFTER NAIL INSERTION, A CONDYLE SCREW WAS INSERTED, BUT IT DID NOT ENGAGE WITH THE NUT AT ALL. ONCE THE SURGEON TRIED TO ENGAGE THEM OUTSIDE THE BODY, BUT IT STILL DIDN'T ENGAGE. ANOTHER SCREW WAS USED TO COMPLETE THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15469646 ↗
• MalfunctionApr 13, 2022Positioning Failure; Positioning Failure

  THE CUSTOMER REPORTED THAT "AS WE HAVE JUST DISCUSSED BY TELEPHONE, I AM SENDING YOU AN E-MAIL TO INFORM YOU OF AN INCIDENT CONCERNING THE PLACEMENT OF A RETROGRADE S2 FEMUR NAIL ON MONDAY. INDEED, WHEN THE TRANSCONDYLAR SCREW WAS PLACED IN COMPRESSION, IT NEVER SCREWED IN DESPITE THE 1.8 PIN AND THE DRILLING ON BOTH SIDES OF THE CONDYLE." ADDITIONAL INFORMATION RECEIVED: "THE PROCEDURE WAS COMPLETED CORRECTLY BUT WITHOUT THIS TRANSCONDYLAR COMPRESSION SCREW. NO CLINICAL CONSEQUENCES TO DATE. YES, THE PROCEDURE WAS DELAYED BY ABOUT 20 MINUTES. NO ADDITIONAL MEDICAL INTERVENTION, BUT WE USED THE IMAGE INTENSIFIER MORE THAN USUAL, WHICH COULD HAVE HAD REPERCUSSIONS ON THE PATIENT AND THE PERSONNEL PRESENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14102939 ↗
• MalfunctionJun 29, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: SUPRACONDYLAR FRACTURE OF THE FEMUR (RIGHT). T2SCN. THE NUT ON THE CONDYLE SCREW CAME OUT ONE WEEK AFTER THE OPERATION. THERE WAS NO PROBLEM WITH THE INSTRUMENT.

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

  MAUDE report 10206618 ↗