NA 04.033.936SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982272645), received between Jan 21, 2019 and Jul 25, 2022 — classified as 3 injuries.

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 3 most recent of 3 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: Fatigue

  MAUDE report 15093330 ↗
• InjuryAug 19, 2019Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018 THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE TO REMOVE A BROKEN ROD WITH SUBSEQUENT REPLACEMENT OF A NEW LARGER ROD. IT WAS REPORTED ON OR ABOUT (B)(6) 2018, THE PATIENT SUFFERED A FRACTURED RIGHT FEMUR DUE TO A VEHICLE ACCIDENT. ON (B)(6) 2018, A SYNTHES INTRAMEDULLARY ROD WAS IMPLANTED TO THE PATIENT. ON OR ABOUT (B)(6) 2018, X-RAYS REVEALED A CLEAR RESULT BUT THE PATIENT WAS STILL SUFFERING FROM A SLIGHT LIMP WITHOUT PAIN. ON OR ABOUT (B)(6) 2018, THE PATIENT HAD SUSTAINED INJURIES FROM SYNTHES PRODUCTS BEING DEFECTIVE. HE FELT A POP AND PAIN IN HIS LEG. X-RAYS REVEALED A FRACTURE OF INTRAMEDULLARY PIN FIXATING A FRACTURE OF THE DISTAL 3RD OF THE FEMORAL DIAPHYSIS WITH MILD APEX ANTERIOR ANGULATION. ON OR ABOUT (B)(6) 2019, AFTER THREE MONTHS OF THERAPY, THE PATIENT WAS RELEASED TO RETURN TO WORK BUT STILL SUFFERING FROM LIMPING AND NOW HAS PAIN IN BOTH HIP AND KNEE WHICH HE DID NOT HAVE PRIOR TO THE ROD FAILURE. THIS COMPLAINT INVOLVES FOUR (4) DEVICES.

  Patient problems: No Code Available

  MAUDE report 8906144 ↗
• InjuryJan 21, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018 , THE PATIENT UNDERWENT REMOVAL OF FEMORAL RECON NAIL AND UNKNOWN THREE (3 )TITANIUM 5.0MM LOCKING SCREWS DUE TO THE NAIL BREAKING, AND REPLACED WITH RETROGRADE FEMORAL NAIL. ORIGINAL IMPLANT DATE WAS ON (B)(6) 2018. NO FRAGMENTS GENERATED FROM THE NAIL, JUST 2 PIECES. BOTH PORTIONS OF THE BROKEN NAIL WERE SUCCESSFULLY REMOVED. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCES REPORTED. THE SURGEON WANTED TO SPEAK WITH SOMEONE ABOUT A POSSIBLE FLAW IN THE DESIGN OF THE NAIL THAT BROKE. HE BELIEVES IT SHOULD HAVE 7 MILLION CYCLES BEFORE FAILURE. THIS PATIENT IS VERY SMALL IN STATURE, AND WAS DOING NOTHING EXCEPT WALKING WHEN THE NAIL FAILED. CONCOMITANT REPORTED DEVICES : TITANIUM 5.0MM LOCKING SCREWS (PART#UNKNOWN, LOT#UNKNOWN. QUANTITY 3). THIS REPORT IS FOR ONE (1) 9MM / TI CANN FRN / PF 360MM / RIGHT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8264650 ↗