NA 04.033.070SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982272027), received between Jul 24, 2018 and Mar 18, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE SURGEON WAS TREATED THIS PATIENT WITH FRNA GT NAIL. WHILE IMPLANTING THE FEMORAL NAIL A 3.2X400 WIRE MISSED THE HOLE THROUGH THE NAIL. THE WIRE WAS HITTING THE NAIL AT AN INCORRECT ANGLE AND UNDER XRAY IMAGING SEE THE TRAJECTORY WASN¿T THE SAME AS THE TRACER TRAJECTORY. THIS STEP IN THE SURGICAL TECHNIQUE WAS REPEATED SEVERAL TIMES TO SEE WHY THIS STEP WASN¿T WORKING. THIS CREATED AN ISSUE BECAUSE THE SECOND RECON SCREW WASN'T ABLE TO BE IMPLANTED AS IT WOULDN¿T FIT THROUGH THE NAIL. THERE WASN¿T A DELAY IN SURGERY CAUSE BY THIS EVENT. THE FRNA IMPLANT HAS TWO DIFFERENT PROXIMAL LOCKING OPTIONS. "RECON LOCKING¿ AND THE OTHER ¿STANDARD LOCKING¿. SINCE RECON LOCKING WASN¿T WORKING THE SURGEON WAS ABLE TO PREFORM ¿STANDARD LOCKING¿ . THE SURGERY WAS COMPLETED SUCCESSFULLY. NO ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT. THIS REPORT IS FOR ONE (1)10 / TI CANN FRN / GT 400 / RIGHT - SILE. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18921834 ↗
• InjuryJul 24, 2018Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A PROCEDURE TO IMPLANT A 10MM CANNULATED FEMORAL RECON NAIL (FRN) ON (B)(6) 2018. DURING THE PROCEDURE, THE NAIL BECAME LODGED IN THE PATIENT¿S PROXIMAL FEMUR, AS THE OPENING REAMER OF THE NAIL DID NOT ALLOW FOR THE NAIL TO BE FULLY INSERTED. SURGEON ATTEMPTED TO BACK THE NAIL OUT BUT WAS NOT SUCCESSFUL. SURGEON WAS FORCED TO PROCEED WITH INSERTION OF THE NAIL AND WAS EVENTUALLY ABLE TO SEAT THE NAIL, BUT ONLY LOW ENOUGH TO ALLOW FOR ONE (1) PROXIMAL FEMORAL RECON SCREW TO BE IMPLANTED. SURGEON WAS THEN ABLE TO USE THE NAIL¿S DISTAL LOCKING OPTIONS TO COMPLETE THE PROCEDURE WITH A DELAY OF APPROXIMATELY 60 MINUTES. THIS REPORT IS FOR ONE (1) 10MM CANNULATED FRN NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Not Applicable

  MAUDE report 7716182 ↗