NA 04.005.546Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982086143), received between Aug 23, 2019 and Jul 19, 2022 — classified as 6 injuries.

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.

• 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: Post Operative Wound Infection

  MAUDE report 15054959 ↗
• 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: Swelling/ Edema

  MAUDE report 15052980 ↗
• 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: Swelling/ Edema

  MAUDE report 15052964 ↗
• InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, A PATIENT UNDERWENT A PROCEDURE TO TREAT THE DISTAL TIBIA AND FIBULA FRACTURE WITH A TIBIA NAIL AND FIBULA PLATE. THE PATIENT HAD ZERO HEALING PROPERTIES AND CONSEQUENTLY, THE PATIENTS DISTAL LEG WAS QUITE ROTTING OFF. ON (B)(6) 2021 THE TIBIA NAIL ALONG WITH FIVE (5) 5.0MM LOCKING SCREWS WERE REMOVED AND PATIENT'S LEG WAS AMPUTATED BELOW THE KNEE. CLINICAL OUTCOME EXPERIENCED BY THE PATIENT WAS INFECTION. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 56MM FOR IM NAILS. THIS IS REPORT 5 OF 7 FOR (B)(4).

  Patient problems: Necrosis; Unspecified Infection

  MAUDE report 12779353 ↗
• InjuryJul 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A REMOVAL OF HARDWARE DUE TO INFECTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR (1) 5.0 TI LCKNG SCR T25 SD 56 FOR IM NAILS. THIS REPORT IS 4 OF 6 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12199736 ↗
• InjuryAug 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT HARDWARE REMOVAL OF TIBIAL INTRAMEDULLARY NAIL DUE TO NONUNION. WHILE REMOVING NAIL BROKE AND PIECE WAS LEFT IN PATIENT. THE FRAGMENTS WAS REMOVED EASILY, PROCEDURE WAS COMPLETED SUCCESSFULLY WITH LESS THAN 5 MINUTES SURGICAL DELAY. IM NAIL REMOVED AND PLATED DURING PROCEDURE. PATIENT OUTCOME IS UNKNOWN. THIS REPORT CAPTURES POST-OP EVENT OF HARDWARE REMOVAL DUE TO NON-UNION. RELATED COMPLAINT (B)(4) CAPTURES INTRA-OP EVENT OF NAIL BREAKAGE DURING REMOVAL. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW STARDRIVE 56MM FOR IM NAILS. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 8926069 ↗