NA 04.033.064SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982271990), received between Apr 27, 2020 and Apr 27, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device Problem” (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.

• InjuryApr 27, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING A FEMORAL RECON NAILING OF 1/3 SHAFT FRACTURED FEMUR ON THE PATIENT, THE RIGHT TITANIUM CANNULATED FEMORAL RECON NAIL WAS BECOMING INCARCERATED WITHIN THE FEMORAL SHAFT. THE SURGEON HAD TO REAMED UP TO 12MM FOR THE INSERTION OF THE 10MM NAIL. UPON REMOVAL OF THE INCARCERATED NAIL, THERE WAS FEMORAL NECK FRACTURE. AFTER THE REMOVAL OF THE 10MM NAIL, A 9MM NAIL WAS INSERTED, AND THE FEMORAL NECK FRACTURE WAS REDUCED AND FIXATED WITH 6.5 CANNULATED SCREWS. THE SURGEON HAD TO REAM TO 14.5MM IN ORDER TO INSERT THE 9MM NAIL. THE SURGEON COMPLAINT THAT THE PROXIMAL PORTION OF THE NAIL WAS TOO WIDE IN DIAMETER, THEREFORE RESULTING IN THE INCARNATION DUE TO THE LONG OR WIDE PROXIMAL TAPER OF THE FEMORAL RECON NAIL. THE MEDICAL INTERVENTION REQUIRED SINCE, THEY HAD TO CHANGE TABLES TO INSERT 6.5 CANNULATED SCREWS INTO THE FEMORAL NECK AFTER THE INSERTION OF THE 9MM NAIL AND EXTRA X-RAYS WERE NEEDED. THERE WAS A SURGICAL DELAY APPROXIMATELY OF ONE HOUR AND SIXTY (60) MINUTES. PROCEDURE SUCCESSFULLY COMPLETED. PATIENT STATUS IS GOOD. CONCOMITANT DEVICES REPORTED: UNKNOWN REAMER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES ON

  Patient problems: Injury; Not Applicable

  MAUDE report 10002256 ↗