NA 04.168.275SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982274694), received between Sep 6, 2019 and Aug 28, 2024 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN ORIF WITH FNS FOR FEMORAL NECK FRACTURE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON (B)(6) 2024, A REMOVAL SURGERY WAS PERFORMED. THE PREOPERATIVE X-RAY SHOWED BONE HEALING FAILURE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE (1) BOLT FOR FEMORAL NECK SYS 75 LENGTH -S. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 20090028 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6), 2023, THE SURGEON REMOVED AN FNS (FEMORAL NECK SYSTEM) IMPLANT AND INSERTED A NON-SYNTHES FEMORAL NAIL. THE PATIENT HAD BROKEN THEIR FEMUR AT THE LEVEL OF THE DISTAL END OF THE FNS PLATE. THE PATIENT VOICED THAT SHE TWISTED HER LEG AND FELT HER LEG SNAP. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE BOLT FOR FEMORAL NECK SYSTEM 75MM LENGTH - STERILE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Limb Fracture

  MAUDE report 18046040 ↗
• InjurySep 22, 2023Migration; Migration

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 , THE PATIENT UNDERWENT AN ORIF SURGERY WITH FNS IMPLANTS FOR A FEMORAL NECK FRACTURE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER SURGERY, CUT-OUT OCCURRED. THE FNS IMPLANTS WILL BE REMOVED, AND A REVISION THA WAS SCHEDULED TO BE PERFORMED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A BOLT FOR FEMORAL NECK SYSTEM 75MM LENGTH ¿ STERILE. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17802874 ↗
• MalfunctionDec 9, 2022Use of Device Problem; Appropriate Device Problem Term/Code Not Available; Use of Device Problem; Appropriate Device Problem Term/Code Not Available

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION WITH THE FNS FOR THE FEMORAL NECK FRACTURE. THE GUIDEWIRE MEASURED 72.5 MM, AND THE SURGEON SELECTED 70 MM BOLT. HOWEVER, THERE WERE NO APPROPRIATE SIZE OF BOLT AND ANTIROTATION SCREW. THEREFORE, THE 75 MM BOLT AND THE 75 MM ANTIROTATION SCREW WERE USED. THE BOLT SLID 10 MM. DURING REAMING AT 70 MM, IT WAS NOT POSSIBLE TO REAM TO THE OUTER CORTEX, AND THE BOLT WAS SLIGHTLY FLOATED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A BOLT FOR FEMORAL NECK SYSTEM 75MM LENGTH ¿ STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15950119 ↗
• InjurySep 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON WAS CONVERTING THE PATIENT TO TOTAL HIP ARTHROPLASTY. THE PATIENT WAS EXPERIENCING PAIN AND NEEDED TO REMOVE A FEMORAL NECK SYSTEM PLATE AND SCREWS. NOTHING WAS BROKEN. THE 5.0 MM LOCKING SCREW WAS STRIPPED BUT WAS REMOVED SUCCESSFULLY. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) BOLT FOR FEMORAL NECK SYSTEM 75MM LENGTH - STERILE. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10496951 ↗
• InjurySep 6, 2019No Apparent Adverse Event; No Apparent Adverse Event

  IT IS REPORTED THAT ON AN (B)(6) 2019, THE PATIENT UNDERWENT A REVISION OF A FEMORAL NECK SYSTEM (FNS) DUE TO A SUBTROCHANTERIC FRACTURE JUST BELOW THE SCREW OF THE FEMORAL NECK SYSTEM (FNS) PLATE. THE PATIENT WAS FIXED WITH FEMORAL NECK SYSTEM OR FEMORAL NECK FRACTURE APPROXIMATELY 13 WEEKS AGO. THE FEMORAL NECK WITH SEALED WHEN THE IMPLANT WAS REMOVED. THERE WAS NO BROKEN HARDWARE JUST THE SUBTROCHANTERIC FRACTURE BELOW THE PLATE. THE HARDWARE WAS REMOVED WITHOUT A BENT AND THE SUBTROCHANTERIC FRACTURE WAS FIXED WITH LONG A PROXIMAL FEMORAL NAILING SYSTEM (TFNA) 11X63MM 125-DEGREE RIGHT SIDE AND 80MM HELICAL BLADE AND DISTAL LOCKING SCREW. PROCEDURE OUTCOME AND PATIENT STATUS WERE UNKNOWN. THIS REPORT IS FOR ONE (1) BOLT FOR FEMORAL NECK SYSTEM 75MM LENGTH - STERILE. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 8969724 ↗