NA 04.005.534Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10886982086020), received between Feb 28, 2018 and Jul 25, 2022 — classified as 14 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 reports).

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 15 most recent of 15 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: Pain

  MAUDE report 15093676 ↗
• 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 (B)(6) 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, LFN WAS NOT

  Patient problems: Loss of Range of Motion

  MAUDE report 15093493 ↗
• InjuryJul 21, 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 (B)(6) 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, LFN WAS NOT

  Patient problems: Embolism/Embolus

  MAUDE report 15075024 ↗
• InjuryJul 21, 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 (B)(6) 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, LFN WAS NOT

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15074655 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER THAT POSTOPERATIVELY TO AN UNKNOWN SURGERY ON AN UNKNOWN DATE, A PATIENT UNDERWENT A DEVICE REMOVAL IN THE LEFT ANKLE ON (B)(6) 2022 DUE TO PAIN. IT WAS REPORTED THAT THE PATIENT WAS DOING WELL . NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR (1) 5.0 TI LCKNG SCR T25 SD 44 FOR IM NAILS DEVICE. THIS COMPLAINT INVOLVES (3) DEVICES.

  Patient problems: Pain

  MAUDE report 14146928 ↗
• 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 44MM FOR IM NAILS. THIS IS REPORT 2 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 13560183 ↗
• 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 THIRTEEN (13) DEVICES. THIS REPORT IS FOR (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 44MM FOR IM NAILS. THIS REPORT IS 4 OF 13 FOR (B)(4).

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

  MAUDE report 12356628 ↗
• InjuryAug 12, 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 PROCEDURE DUE TO AN INFECTION OF A LEFT TIBIAL FRACTURE. INITIALLY, THE ORIGINAL DATE OF THE SURGERY WAS ON (B)(6) 2021. POST OP EVALUATION WAS AN INFECTION, DECISION WAS MADE TO REMOVED HARDWARE. ALL ITEMS WERE INTACT THERE WERE NO FRAGMENTS, NO BROKEN PIECES. PATIENT HAS TURN SURGERY WELL AND WAS DOING FINE POSTOPERATIVELY. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM FOR IM NAILS. THIS REPORT IS 2 OF 6 FOR (B)(4).

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

  MAUDE report 12316220 ↗
• InjuryMay 27, 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 A REVISION SURGERY DUE TO A NON-UNION OF THE LEFT TIBIAL SHAFT. THE IMPLANTS THAT WERE REMOVED WERE TITANIUM CANNULATED TIBIAL NAIL, END CAP, AND THREE TITANIUM LOCKING SCREWS. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 44MM FOR IM NAILS. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11894431 ↗
• InjuryMay 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 THE PATIENT UNDERWENT A REVISION SURGERY DUE TO A NON-UNION OF THE RIGHT FEMORAL SHAFT. THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2020. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS DOING FINE POSTOPERATIVELY. THE IMPLANTS REMOVED WERE INTACT AND NOT BROKEN AND WERE REVISED WITHOUT COMPLICATIONS. THE REVISION WAS FINE POST-OPERATIVELY. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 44MM FOR IM NAILS. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11859415 ↗
• InjuryMar 16, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT UNDERWENT FOR REMOVAL OF BROKEN PFNA. THE PFNA WAS COMPLETELY REMOVED FROM THE PATIENT. THE PFNA HAD BEEN IN SITU FOR OVER A YEAR. THIS WAS ALREADY A REVISION PFNA AND HAD BEEN USED WITH AUGMENT. NONE OF THE HCP¿S PRESENT HAD A COMPLAINT ABOUT THE IMPLANT FAILING. IT WAS UNKNOWN IF THE REMOVAL SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN PFNA HELICAL BLADE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 44MM FOR IM NAILS. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11494677 ↗
• InjuryAug 9, 2019Break; Break

  ON (B)(6) 2018, THE PATIENT HAD A REMOVAL OF THE TITANIUM LOCKING SCREW DUE TO INCREASED PAIN AND BASED ON THE X-RAY THAT WAS TAKEN ON MARCH 25, 2018 REVEALED RIGHT FEMUR NECK FRACTURE OF THE PROXIMAL HARDWARE SCREWS AND A FRACTURED HIP BALL. THE PATIENT ALSO UNDERWENT A TOTAL RIGHT HIP ARTHROPLASTY. ON (B)(6) 2017, THE PATIENT FELL FROM THE BASEMENT STAIRS. ON (B)(6) 2017, THE PATIENT WAS SENT TO MERCY HOSPITAL, ST. LOUIS AND WAS IMPLANTED WITH UNKNOWN TITANIUM ROD AND TITANIUM LOCKING SCREW. ON (B)(6) 2017, AFTER 10 MONTHS OF CONTINUOUS AND INCREASING PAIN THE PATIENT HAD AN X-RAY OF THE PATIENTS HIP AND IMPLANT AND SHOWED NORMAL RECOVERY AND EXPLAINED THAT THE PAIN WOULD GRADUALLY DIMINISH. ON (B)(6) 2018, AN ADJUSTMENT WAS DONE TO PLACE DISLOCATED HIP BALL BACK INTO PROPER POSITION OF HER RIGHT HIP. ON (B)(6) 2018, IT WAS REPORTED THAT THE SCREWS WERE BROKEN WITHOUT ACCIDENT OR IMPACT. THE PATIENT STILL SUFFERS FROM PAIN AND HAS DIFFICULTY WITH MOVEMENT AND BALANCE SINCE THE EFFORT TO STABILIZE HER FRACTURED LEG. THERE WAS AN ADDITION OF AN INCH OF LEG LENGTH TO HER FRACTURED LEG WITH THE COMPLICATIONS FROM BROKEN SCREWS AND HAS SUBSEQUENTLY FRACTURED HER SACRUM VERTICALLY AND

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

  MAUDE report 8878945 ↗
• 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 8454457 ↗
• InjuryNov 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HARDWARE REMOVAL ON (B)(6) 2018, DUE TO NEEDING A TOTAL HIP ARTHROPLASTY. PATIENT WAS INITIALLY IMPLANTED APPROXIMATELY NINE (9) MONTHS PRIOR TO REMOVAL. THERE WAS NO FAILURE OR IMPLANT ISSUES. SURGEON HAD NO ISSUES TAKING OUT THE HARDWARE AND THE IMPLANTS PERFORMED AS EXPECTED. THERE WAS NO SURGICAL DELAY. THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) SCREW, TITANIUM LOCKING SCREW, AND 130 DEGREE TITANIUM CANNULATED TFNA NAIL WERE ALL SUCCESSFULLY REMOVED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 5.0MM LOCKING SCREW. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8032420 ↗
• MalfunctionFeb 28, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT A PATIENT WITH AN INITIALLY IMPLANTED TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) UNDERWENT REMOVAL OF ONE (1) TFNA NAIL, ONE (1) LAG SCREW AND TWO (2) LOCKING BOLTS ON (B)(6) 2017 DUE TO NONUNION, BROKEN NAIL AND A SUSPECTED INFECTION. THE PATIENT WAS INITIALLY IMPLANTED WITH THE CONSTRUCT IN (B)(6) 2017. SUBSEQUENTLY, THE PATIENT REACHED OUT TO THE EMERGENCY AMBULATORY CARE ON (B)(6) 2017, WHERE AN UNKNOWN NUMBER OF X-RAYS TAKEN CONFIRMED THAT THE PATIENT HAD A HIP DEFORMITY AND THAT THE TFNA NAIL WAS BROKEN IN TWO PIECES. THE REMOVAL OF THIS TFNA CONSTRUCT WAS SCHEDULED FOR THE NEXT DAY, I.E. (B)(6) 2017. THE SURGEON BELIEVED THAT THERE WAS A POSSIBLE INFECTION AT THE SITE OF THE BROKEN TFNA ALONG WITH THE NONUNION AND DECIDED TO USE AN ANTIBIOTIC SPACER TO FIGHT OFF THIS SUSPECTED INFECTION. TISSUE CULTURES WERE ALSO TAKEN TO CONFIRM IF THERE WAS AN INFECTION AT THE SITE, AND THE CULTURE TEST CAME OUT TO BE NEGATIVE. THE SURGEON PLANS TO REVISE THE PATIENT TO A BLADE PLATE IN ORDER TO FIX THE FRACTURE. THE REMOVAL OF TFNA WAS SUCCESSFULLY COMPLETED WITH THE PATIENT IN STABLE CONDITION. NO ADDITIONAL INTERVENTIONS WERE REQUIRED TO COMPLETE THE SURGERY. DURING

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7303444 ↗