NA 04.005.538Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886982086068), received between Jun 13, 2018 and Sep 13, 2022 — classified as 14 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 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2022 THAT THE PATIENT ORIGINALLY UNDERWENT SURGERY FOR A SUBTROCHANTERIC FEMUR FRACTURE IN (B)(6) 2022, TREATED WITH A TFNA NAIL, HELICAL BLADE, AND LOCKING SCREW. THE FRACTURE WENT ON TO NON-UNION AND THE NAIL FRACTURED AT THE PROXIMAL HELICAL BLADE APERTURE. ON (B)(6) 2022, THE NAIL, HELICAL BLADE, AND SCREW WERE REMOVED WITHOUT INCIDENT. A NEW TFNA NAIL, HELICAL BLADE, AND LOCKING SCREW WERE INSERTED. THIS REPORT INVOLVES ONE 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 48MM FOR IM NAILS. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15410613 ↗
• 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 (B)(6): A 32-YEAR-OLD MALE PATIENT HAD A WEAKNESS IN LEG, WHICH RESOLVED WITH PHYSICAL THERAPY. PATIENT (B)(6): AN 81-YEAR-OLD MALE PATIENT HAD A PERSISTENT SWELLING ABOUT KNEE 1.5 YEARS POSTOPERATIVELY, COMPRESSION. PATIENT (B)(6): A 58-YEAR-OLD FEMALE PATIENT HAD A PULMONARY EMBOLISM. PATIENT (B)(6): A 35-YEAR-OLD FEMALE PATIENT HAD DIFFICULT REDUCTION INTRAOPERATIVELY AND HAD RESIDUAL SORENESS AT INCISION SITE POSTOPERATIVELY. PATIENT (B)(6): A 16-YEAR-OLD MALE PATIENT HAD PAIN WITH IMPLANTS LEADING TO REHOSPITALIZATION FOR ADJ

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15093200 ↗
• InjuryJul 20, 2022Migration; Migration

  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: Failure of Implant

  MAUDE report 15065069 ↗
• InjuryApr 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS REMOVAL OF TIBIAL NAIL DUE TO INFECTION. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED.

  Patient problems: Unspecified Infection

  MAUDE report 14119452 ↗
• InjuryFeb 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, PATIENT UNDERWENT A REMOVAL OF NAIL DUE TO NONUNION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 48MM FOR IM NAILS. THIS IS REPORT 4 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 13560184 ↗
• InjuryAug 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A REMOVAL SURGERY. DURING THE SURGERY, ALL DEVICES WERE INTACT, NO ITEMS WERE BROKEN, AND WERE REMOVED SUCCESSFULLY AND WITHOUT DIFFICULTY. ORIGINALLY, THE PATIENT UNDERWENT FOR REMOVAL HARDWARE OF A LEFT TIBIAL SHAFT FRACTURE FOR INFECTION ON (B)(6) 2020. THE CURRENT REMOVAL SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THE PATIENT WAS FIN POSTOPERATIVELY. THIS COMPLAINT INVOLVES 13 DEVICES. THIS REPORT IS FOR (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 48MM FOR IM NAILS. THIS REPORT IS 10 OF 13 FOR (B)(4).

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

  MAUDE report 12356667 ↗
• InjuryJul 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 THAT THE PATIENT UNDERWENT THE REMOVAL OF IMPLANTS DUE TO AN INFECTED NONUNION OF THE RIGHT TIBIA. ALL DEVICES WERE REMOVED SUCCESSFULLY. THERE WERE NO BROKEN IMPLANTS. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE ORIGINAL DATE OF IMPLANT WAS (B)(6) 2020. THIS REPORT IS FOR ONE (1) 55.0MM TI LOCKING SCREW W/T25 STARDRIVE 48MM FOR IM NAILS. THIS IS REPORT 4 OF 6 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 12204657 ↗
• InjuryJul 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 THAT THE PATIENT UNDERWENT THE REMOVAL OF IMPLANTS DUE TO AN INFECTED NONUNION OF THE RIGHT TIBIA. ALL DEVICES WERE REMOVED SUCCESSFULLY. THERE WERE NO BROKEN IMPLANTS. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE ORIGINAL DATE OF IMPLANT WAS (B)(6) 2020. THIS REPORT IS FOR ONE (1) 55.0MM TI LOCKING SCREW W/T25 STARDRIVE 48MM FOR IM NAILS. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 12204585 ↗
• 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 HARDWARE REMOVAL OF NAIL, HELICAL BLADE, AND LOCKING SCREWS FOLLOWED BY A TOTAL HIP REPLACEMENT SURGERY DUE TO TERRIBLE ARTHRITIS. INITIALLY, THE PATIENT WAS IMPLANTED WITH A TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) ON AN UNKNOWN DATE. THE HARDWARE REMOVAL AND TOTAL HIP REPLACEMENT SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: 12MM/130 DEG TI CANN TFNA 420MM/RIGHT-STERILE (PART NUMBER 04.037.262S, LOT H735696, QUANTITY 1). TFNA FENESTRATED HELICAL BLADE 100MM (PART NUMBER 04.038.400, LOT H556431, QUANTITY 1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 48MM FOR IM NAILS (PART NUMBER 04.005.538, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 48MM FOR IM NAILS. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Arthritis

  MAUDE report 11140406 ↗
• 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 HARDWARE REMOVAL OF NAIL, HELICAL BLADE, AND LOCKING SCREWS FOLLOWED BY A TOTAL HIP REPLACEMENT SURGERY DUE TO TERRIBLE ARTHRITIS. INITIALLY, THE PATIENT WAS IMPLANTED WITH A TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) ON AN UNKNOWN DATE. THE HARDWARE REMOVAL AND TOTAL HIP REPLACEMENT SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: 12MM/130 DEG TI CANN TFNA 420MM/RIGHT-STERILE (PART NUMBER 04.037.262S, LOT H735696, QUANTITY 1); TFNA FENESTRATED HELICAL BLADE 100MM (PART NUMBER 04.038.400, LOT H556431, QUANTITY 1); 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 48MM FOR IM NAILS (PART NUMBER 04.005.538, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 48MM FOR IM NAILS. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Arthritis

  MAUDE report 11140385 ↗
• InjuryApr 29, 2020Adverse 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 SURGERY OF THE PROXIMAL FEMORAL NAILING SYSTEM (TFNA). THE PATIENT WITH LONG TFNA FELL IN REHAB AND SUFFERED A DISPLACED DISTAL FEMUR FRACTURE. THE LONG NAIL WAS REPLACED WITH SHORT NAIL AND A VARIABLE ANGLE LOCKING COMPRESSION PLATE DISTAL FEMUR PLATE WAS APPLIED DISTALLY. THE ORIGINAL DATE OF IMPLANT WAS ON (B)(6) 2020. THE PROCEDURE OUTCOME IS UNKNOWN. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 48MM FOR IM NAILS. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 10011752 ↗
• InjuryMar 26, 2019Break; Break

  UPDATE: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION OF THE TIBIA DIAPHYSEAL SEGMENT. THE TITANIUM CANNULATED TIBIAL NAIL-EX WITH PROXIMAL BEND WAS REMOVED. ONE (1) TITANIUM (TI) LOCKING SCREW WITH T25 STARDRIVE RECESS 36MM, ONE (1) LOCKING SCREW WITH T25 STARDRIVE RECESS 36MM, ONE (1) LOCKING SCREW WITH T25 TI STARDRIVE RECESS 60MM, ONE (1) LOCKING SCREW WITH T25 TI STARDRIVE RECESS 44MM,ONE (1) LOCKING SCREW WITH T25 TI STARDRIVE RECESS 48MM, ONE (1) LOCKING SCREW WITH T25 TI STARDRIVE RECESS 48MM, AND ONE (1) LOCKING SCREW WITH T25 TI STARDRIVE RECESS 54MM WAS REMOVED DUE TO A NON-UNION . IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOMES WERE UNKNOWN. THERE WERE NO PATIENT CONSEQUENCES.

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

  MAUDE report 8454453 ↗
• InjuryDec 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TROCHANTERIC FEMORAL NAIL ADVANCE (TFNA) HARDWARE WAS REMOVED DUE TO A FEMORAL NECK FRACTURE. BOTH THE TFNA NAIL AND LOCKING SCREWS WERE NOT BROKEN. THE PATIENT WAS REVISED/REPLACED WITH A HEMI-ARTHROPLASTY. THERE WAS AN UNSPECIFIED SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 48MM FOR IM NAILS THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 8206427 ↗
• InjuryJun 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RIGHT FEMUR ON (B)(6) 2017. THE PATIENT UNDERWENT REMOVAL OF ONE (1) 10MM TITANIUM LATERAL FEMORAL RECON NAIL, ONE (1) 5.0MM TITANIUM LOCKING SCREW WITH T25 STARDRIVE 48MM, ONE (1) 5.0MM TITANIUM LOCKING SCREW WITH T25 STARDRIVE 54MM AND TWO (2) 6.5MM TITANIUM RECON SCREW WITH T25 STARDRIVE 100MM ON (B)(6) 2018 DUE TO POST-OPERATIVE PAIN. ALL THE HARDWARE WAS REMOVED INTACT. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS STABLE. THIS REPORT IS FOR ONE (1) 5.0MM LOCKING SCREW 48MM. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7598392 ↗