Stainless Steel Femoral Nailing System 1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18032568033724), received between Feb 19, 2025 and Feb 19, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical 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.

• MalfunctionFeb 19, 2025Mechanical Problem; Mechanical Problem

  THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: EVENT NOTIFIED BY THE HOSPITAL TO ANSM; ANSM REF: (B)(4) HOSPITAL NAME: (B)(6) DATE OF SURGERY: ON (B)(6) 2025 SURGERY DESCRIPTION: FRACTURE TREATMENT PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM EVENT DESCRIPTION: "CUSTOMER STATEMENT: WE INFORM YOU OF A SERIOUS INCIDENT WHICH OCCURRED ON FEBRUARY 7, 2025, DURING A LONG GAMMA NAIL OPERATION. DURING THE OPERATION, THE SIZE 12.5 REAMER REFERENCE (B)(4) FROM THE BOX OF MONOBLOC REAMERS N°1 COMPLETELY UNWOUND INSIDE THE PATIENT. THE REMOVAL OF THIS MATERIAL LASTED 2 HOURS WITH LOSS OF LUCK FOR THE PATIENT". THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE: 2 HOURS PRODUCT IS AVAILABLE FOR RETURN. ON FEBRUARY 12, 2025, ORTHOFIX RECEIVED THE FOLLOWING ADDITIONAL DETAILS: "IT TOOK 2 HOURS TO EXTRACT THE REAMER FROM THE CENTROMEDULLARY CANAL. THIS PROLONGED THE INITIAL OPERATION. SO FAR, NO FURTHER COMPLICATIONS FOR THE PATIENT". MANUFACTURER REF: 2025

  Patient problems: Oversedation

  MAUDE report 21410020 ↗