NA 04.168.480SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982274588), received between Jan 8, 2021 and Sep 6, 2022 — classified as 5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 6, 2022Adverse 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) 2022, THE PATIENT UNDERWENT ORIF SURGERY FOR A FEMORAL NECK FRACTURE WITH FNS IMPLANTS. AFTER SURGERY ON (B)(6) 2022, THE PATIENT COMPLAINED OF PAIN, AND SUBTROCHANTERIC FRACTURE OF FEMUR AT THE AREA WHERE THE LOCKING SCREW OF FNS WAS INSERTED WAS CONFIRMED. ON (B)(6) 2022, A REVISION SURGERY WAS PERFORMED. IN THE REVISION SURGERY, FNS IMPLANTS WERE REMOVED AND REPLACED WITH FEMORAL RECON NAIL IMPLANTS TO FIX THE FRACTURE SITE. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A ANTIROTATION SCREW FOR FEMORAL NECK SYS 80MM LENGTH - STERIL. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 15364620 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION SURGERY FOR FEMORAL NECK FRACTURE WITH THE FNS IMPLANTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE BONE UNION FAILURE WAS CONFIRMED ON AN UNKNOWN DATE. A REVISION SURGERY PERFORMED ON (B)(6) 2022. THE FNS IMPLANTS WERE REMOVED AND REPLACED WITH THA. THE PATIENT WAS REPORTED AS STABLE. THIS REPORT INVOLVES ONE (1) ANTIROTATION SCREW FOR FEMORAL NECK SYS 80MM LENGTH: STERIL. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Malunion of Bone

  MAUDE report 14702763 ↗
• InjuryJun 3, 2021Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY OF THE FEMORAL NECK SYSTEM DUE TO CUT OUT ON (B)(6) 2021. CONVERTING TO A HEMIARTHROPLASTY. PROCEDURE OUTCOME WAS UNKNOWN, AND PATIENT HAS CONSEQUENCES. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) ANTIROTATION SCR FEM NECK 80 LNTH -S THIS REPORT IS 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11932274 ↗
• InjuryMar 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT CAPTURES THE POST-OP EVENT OF REVISION DUE TO STRESS RISERS AT THE LEVEL OF THE SHAFT SCREW, WHILE RELATED COMPLAINT (B)(4) REPORTS THE INTRA-OP EVENT OF THE SHAFT SCREW THAT WOULD NOT COME OUT, SO THE SURGEON HAD TO CUT THE PLATE. THIS REPORT IS FOR ONE (1) ANTIROTATIONAL SCREW FOR FEMORAL NECK SYS 80MM LENGTH - STERIL THIS IS REPORT 4 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 11572331 ↗
• MalfunctionMar 8, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT HIP REVISION SURGERY DUE TO MALUNION AND FEMORAL NECK COLLAPSE. THE SURGEON REMOVED ONE (1) FEMORAL NECK SYSTEM PLATE, ONE (1) FEMORAL NECK BOLT, ONE (1) ANTIROTATION FEMORAL NECK SCREW, AND ONE (1) 5MM TI LOCKING SCREW. THE ORIGINAL PROCEDURE DATE IS UNKNOWN. THE HARDWARE WAS REMOVED WITH NO ISSUES. THE PATIENT WAS THEN IMPLANTED WITH A HIP HEMI ARTHROPLASTY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) ANTIROTSCR F/FEM NECK SYST. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Malunion of Bone

  MAUDE report 11438949 ↗
• InjuryJan 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REMOVAL AND REVISION PROCEDURE OF THE FEMORAL NECK SYSTEM (FNS) DEVICES DUE TO A BREAK BELOW THE FNS PLATE SECONDARY TO FALL. INITIALLY, THE PATIENT WAS IMPLANTED WITH THE ORIGINAL DEVICES ON (B)(6) 2020. IT WAS MENTIONED THAT THERE WAS NO HARDWARE THAT WAS BROKEN, JUST THE BONE AROUND IT. DURING THE REVISION PROCEDURE, THE FNS IMPLANTS WERE REMOVED AND THE PATIENT WAS REVISED TO A TROCHANTERIC FIXATION NAIL ADVANCED(TFNA) DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) ANTIROTATION SCREW FOR FEMORAL NECK SYS 80MM LENGTH - STERILE. THIS REPORT IS 1 OF 4 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 11142451 ↗