NA 04.033.238SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982271419), received between Sep 27, 2021 and Jul 25, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 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: Loss of Range of Motion

  MAUDE report 15093558 ↗
• MalfunctionSep 27, 2021Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A REVISION USING THE DEPUY SYNTHES FEMORAL RECON NAIL, PIRIFORMIS ENTRY PROCEDURE. INITIALLY PATIENT WAS OPERATED ON IN (B)(6) FIFTEEN YEARS AGO AND WAS NEVER HEALED. PATIENT HAD A MIDSHAFT FEMUR FRACTURE TREATED WITH A PIRIFORMIS ENTRY FEMORAL NAIL OF UNKNOWN MANUFACTURER. THE SURGEON AND HIS PARTNER REAMED UP TO 13.5MM AND USED A 12MM X 380MM RIGHT SIDE NAIL. WHEN THE NURSE OPENED THE PACKAGE, THE SURGEONS COMMENTED ON THE CURVE OF THE NAIL BEING MORE OF A SHARP BEND THAN A CURVE. DURING IMPLANTING THE NAIL, THE NAIL WOULD NOT PASS FURTHER THAN MIDSHAFT DUE TO THE EXTREME BEND OF THE NAIL, AS IT WAS MEETING RESISTANCE BOTH PROXIMALLY AND AT MIDSHAFT. THE SURGEONS ENDED UP HAVING TO OVER-REAM BY (1) - (2)MM BOTH PROXIMALLY AND AT THE ISTHMUS. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH (20) MINUTES DELAY. WE COMPARED A TFNA NAIL WITH THE FRN BECAUSE THEY HAVE THE SAME RADIUS OF CURVATURE, BUT THE CURVE IS DRASTICALLY DIFFERENT IN GEOMETRY. THIS REPORT IS FOR (1) 12 / TI CANN FRN / PF 380 / RIGHT - SILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12538037 ↗