NA 04.033.968SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982272232), received between Nov 5, 2018 and Mar 27, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING FEMORAL RECON NAIL (FRN) INSERTION, THE FRN NAIL BECAME STUCK IN THE CANAL REQUIRING FORCEFUL IMPACTION AND SUBSEQUENT EXTRACTION. THE DRIVING CAP/THREADED BROKE OFF. DURING THE EXTRACTION OF THE FRN NAIL, THE TWO (2) UNIVERSAL CHUCK WITH T-HANDLE BROKE DUE TO FORCEFUL EXTRACTION. ACTION TAKEN WHEN THE EVENT OCCURRED WAS EXTRACTION OF NAIL, NEW REAM ROD INSERTED AND SAME FRN NAIL WAS INSERTED INTO FEMUR. THERE WAS SIXTY (60) MINUTES SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) 9 MM / TI CANN FRN / GT 380MM / RIGHT - STERILE. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11579149 ↗
• MalfunctionJan 8, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020 WHEN PUTTING IN THE PROXIMAL LOCKING SCREW THROUGH THE GUIDE, THE DRILL BIT HIT THE NAIL ON THE FIRST APPROACH. IT APPEARED THAT THE SOFT TISSUE WAS BOUND ON THE SLEEVE AND CAUSED THE DRILL BIT TO HIT THE NAIL. THE SURGEON READJUSTED THE INCISION AND THE DRILL BIT WENT THROUGH THE NAIL WITH EASE AS WELL AS DID THE SCREW. THE NAIL AND THE HANDLE WERE TESTED PRIOR TO NAIL INSERTION TO MAKE SURE THAT THE SLEEVES LINED UP CORRECTLY. THERE WAS NO SURGICAL DELAY AND NO FRAGMENTS GENERATED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT CONSEQUENCE. CONCOMITANT DEVICE: UNKNOWN PROXIMAL LOCKING SCREW (PRODUCT# UNKNOWN, LOT# UNKNOWN, QTY 1). THIS REPORT IS FOR ONE (1) 9 MM / TI CANN FRN / GT 380MM / RIGHT - STERILE. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11139585 ↗
• InjuryNov 5, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING AN UNKNOWN PROCEDURE, ONE (1) TITANIUM FEMORAL RECON NAIL CANNULATED, AND TWO (2) TITANIUM RECON SCREWS DID NOT FUNCTION PROPERLY. THE SURGEON FOLLOWED THE SURGICAL TECHNIQUE REGARDING ENTRY POINT AND INTRAMEDULLARY REAMING. THE SURGEON IMPLANTED THE FEMORAL RECON NAIL BUT IT WAS DIFFICULT TO MALLET THE NAIL INTO THE FEMUR. ONCE THE NAIL WAS SEATED, HE TRIED TO ROTATE THE NAIL USING THE AIMING ARM AND IT WOULD NOT ROTATE. HE THEN BACK SLAPPED THE NAIL, SO IT COULD BE INSERTED WITH MORE ANTI-VERSION, BUT IT WAS VERY DIFFICULT TO INSERT. AFTER THIS, IT WAS MADE SURE THAT THE CANNULATED CONNECTING SCREW WAS SECURE AND TIGHT. ONCE THE NAIL WAS BACK SLAPPED ENOUGH, HE CORRECTED THE ANTI-VERSION AND MALLETED THE FEMORAL RECON NAIL BACK DOWN THE FEMUR. THE CANNULATED CONNECTING SCREW WAS CHECKED ONCE MORE TO MAKE SURE IT WAS SECURE AND TIGHT. THE SURGEON THEN AGAIN STARTED THE PROXIMAL RECON SCREW IMPLANTATION PROCESS, AND THE NAIL WAS STILL AIMING TOO POSTERIOR. THE SURGEON THEN TRIED TO CHANGE THE ROTATION OF THE NAIL BY ROTATING THE AIMING ARM. HE THOUGHT HE WAS IN THE RIGHT POSITION BUT, AFTER COMPLETING THE IMPLANTATION OF THE FEMORAL RECON

  Patient problems: No Code Available

  MAUDE report 8037756 ↗