NA 04.033.966SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982272225), received between Dec 18, 2018 and May 6, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ORIF WITH A NAIL IMPLANT FOR RIGHT FEMORAL SHAFT FRACTURE. ON APRIL 10, 2024, THE SALES REP RECEIVED A REPORT FROM THE AGENCY AND THE SURGEON THAT A PATIENT WITH A RIGHT FEMORAL SHAFT FRACTURE WHO WAS OSTEOSYNTHESIZED USING THE PRODUCT BECAME A FALSE JOINT. (B)(6) 2024, THE NAIL IMPLANT REMOVAL AND REFIXATION ENTAILING PLATE WERE EXPECTED TO BE PERFORMED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 9 MM / TI CANN FRN / GT 360MM / RIGHT - STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 19256043 ↗
• InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ORIF SURGERY FOR A FEMORAL DIAPHYSEAL FRACTURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE ORIGINAL PROCEDURE ON (B)(6) 2023, IT WAS CONFIRMED THAT THE DISTAL FRACTURE LINE BECAME A PSEUDOARTICULATION DESPITE A GOOD RECOVERY POSITION. NAIL REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2023. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 9 MM / TI CANN FRN / GT 360MM / RIGHT ¿ STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18330244 ↗
• InjuryFeb 10, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REVISION SURGERY DUE TO BROKEN FEMORAL RECON NAIL (FRN). ORIGINALLY, THE PATIENT HAD AN IMPLANTATION ON AN UNKNOWN DATE. POST-SURGERY AFTER A MONTH, THE LEG WAS NOT HEALED. WHEN THE NAIL BROKE AND THE LEG WAS STILL BROKEN. THE IMPLANT WAS SUCCESSFULLY EXPLANTED WITHOUT ANY ISSUE. THERE WAS NO SURGICAL DELAY. THE PATIENT WAS STABLE AFTER THE PROCEDURE. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN LOCKING SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN), UNKNOWN RECON SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY# UNKNOWN), UNKNOWN END CAP (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 9 MM / TI CANN FRN / GT 360MM / RIGHT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9687296 ↗
• InjuryJul 22, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY. THE PATIENT PUT WEIGHT ON THE IMPLANT WHICH CAUSED FEMORAL RECON NAIL GREATER TROCHANTER TO BEND DISTALLY, AS CLAIMED BY THE SURGEON PATIENT WAS NON COMPLIANT. THERE WERE NO BROKEN IMPLANTS. THERE WAS A SURGICAL DELAY OF UNKNOWN NUMBER OF MINUTES AS THE SURGEON HAD TO MANIPULATE THE LEG TO BEND THE NAIL BACK TO ORIGINAL SHAPE FOR REMOVAL. PROCEDURE OUTCOME IS SUCCESSFUL. PATIENT STATUS IS STABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN LOCKING SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN RECON SCREWS (PART# UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). THIS REPORT IS FOR ONE (1) 9 MM TI CANNULATED FEMORAL RECON NAIL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 8812850 ↗
• MalfunctionDec 18, 2018Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN SURGERY, THE SURGEON HAD DIFFICULTY INSERTING THE TITANIUM CANNULATED FEMUR RECON NAIL. THE SURGEON COULD NOT ADVANCE UNTIL HE REAMED THE NAIL FURTHER DISTAL TO THE LESSER TROCHANTER RESULTING IN IT GETTING STUCK. THE SURGEON USED AN UNKNOWN 14MM REAMER TO SEAT THE NAIL FLUSH BUT DID NOT WANT TO PULL IT OUT AGAIN AND REAM FURTHER. THE SURGEON DID NOT WANT TO SPLIT THE FEMUR WHILE TRYING TO HAMMER IT IN FURTHER. IT WAS FURTHER REPORTED THAT THE TAPER OF THE DRIVING END EXTENDS FAR INTO THE DIAPHYSIS TO ACCOMMODATE THE RECON SCREW FEATURES, REQUIRES EXCESSIVE DISTAL REAMING BEYOND THE STANDARD FOR A STARTING REAMER. IT IS AN UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE AND THE PATIENT OUTCOME ARE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8176250 ↗