NA 04.005.630Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982086624), received between Feb 18, 2021 and Jul 19, 2022 — classified as 2 injuries.

1 other recall cover devices cleared under the same FDA submission (K970733); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DDRA) [SUMMARY OF RETROSPECTIVE DATA FOR PATIENTS TREATED WITH THE LATERAL FEMORAL NAIL, ADOLESCENT LATERAL FEMORAL NAIL, AND THE FEMORAL RECON NAIL]. BETWEEN JANUARY 2014 AND OCTOBER 2021, A TOTAL OF 300 PATIENTS (219 PATIENTS TREATED WITH LFN, 56 PATIENTS TREATED WITH ALFN, AND 25 PATIENTS TREATED WITH FRN) WERE INCLUDED IN THE REPORT IF THEY HAD EITHER 9 MONTHS OF FOLLOW-UP OR EVIDENCE OF HEALING. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED IN THE BRONSON METHODIST HOSPITAL¿S ORTHOPEDIC INPATIENT DATABASE: LFN GROUP: PATIENT 5: A 32-YEAR-OLD MALE PATIENT HAD A WEAKNESS IN LEG, WHICH RESOLVED WITH PHYSICAL THERAPY. PATIENT 6: AN 81-YEAR-OLD MALE PATIENT HAD A PERSISTENT SWELLING ABOUT KNEE 1.5 YEARS POSTOPERATIVELY, COMPRESSION. PATIENT 8: A 58-YEAR-OLD FEMALE PATIENT HAD A PULMONARY EMBOLISM. PATIENT 9: A 35-YEAR-OLD FEMALE PATIENT HAD DIFFICULT REDUCTION INTRAOPERATIVELY AND HAD RESIDUAL SORENESS AT INCISION SITE POSTOPERATIVELY. PATIENT 13: A 16-YEAR-OLD MALE PATIENT HAD PAIN WITH IMPLANTS LEADING TO REHOSPITALIZATION FOR ADJUNCTIVE PLATE REMOVAL, L

  Patient problems: Pulmonary Embolism

  MAUDE report 15053070 ↗
• InjuryFeb 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF ONE (1) TI CANNULATED ANTEGRADE FEMORAL NAIL AND THREE (3) LOCKING SCREW ON (B)(6) 2021, DUE TO NONUNION. THERE WAS NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME IS UNKNOWN. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11343124 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K970733. One submission often covers many models, so check the product and lot details in each record.

• Z-2243-2013 · Apr 18, 2013 · Terminated
  Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant device.