NA 04.168.475SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982274571), received between Sep 4, 2020 and Aug 28, 2024 — classified as 3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 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) ANTIROTATION SCR FEM NECK 75 LNTH -S. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 20089860 ↗
• 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 AN ANTIROTATION SCREW FOR FEMORAL NECK SYS 75MM LENGTH ¿ STERIL. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17802076 ↗
• 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 AN ANTIROTATION SCREW FOR FEMORAL NECK SYS 75MM LENGTH ¿ STERIL. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15950122 ↗
• 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 5 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR 1 ANTIROTATION SCREW FOR FEMORAL NECK SYS 75MM LENGTH - STERILE. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10497074 ↗