NA 04.005.530Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10886982085986), received between Jan 4, 2018 and Aug 11, 2023 — classified as 34 injuries.

The most frequently reported specific device problem is “Break” (4 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 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 , A PATIENT CAME IN FROM AN OUTSIDE INSTITUTION WITH A NON UNION OF THE FEMUR FOR A REVISION SURGERY. SURGEON REMOVED ALL IMPLANTS INCLUDING NAIL, AND 4 SCREWS. SURGEON REVISED FEMUR FRACTURE SITE, AND REINSERTED NAIL THAT WAS INITIALLY PLACED WITH NEW SCREWS. REVISION SURGERY COMPLETED SUCCESSFULLY. ORIGINAL IMPLANT DATE WAS UNKNOWN. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM FOR IM NAILS. THIS IS REPORT 3 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17512296 ↗
• InjuryNov 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 THE PATIENT HAD A POST OP FALL AND FRACTURED FEMUR DISTAL TO THE TFNA NAIL THAT WAS IMPLANTED. SURGEON REMOVED TFNA WITHOUT INCIDENT IN ORDER TO FIX THE NEW FRACTURE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE 5.0 TI LCKNG SCR T25 SD 40 FOR IM NAILS. THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Fall; Limb Fracture

  MAUDE report 15709072 ↗
• InjuryNov 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 THE PATIENT HAD A POST OP FALL AND FRACTURED FEMUR DISTAL TO THE TFNA NAIL THAT WAS IMPLANTED. SURGEON REMOVED TFNA WITHOUT INCIDENT IN ORDER TO FIX THE NEW FRACTURE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) 5.0 TI LCKNG SCR T25 SD 40 FOR IM NAILS. THIS IS REPORT 3 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Fall; Limb Fracture

  MAUDE report 15709023 ↗
• InjuryOct 4, 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 REMOVAL OF HARDWARE DUE TO POSSIBLE INFECTION. UNKNOWN SCREW LENGTHS. NO SURGICAL DELAY WAS THERE. THE PROCEDURE SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. PATIENT CONSEQUENCES WERE UNKNOWN. THIS REPORT IS FOR ONE (1) 5.0 TI LCKNG SCR T25 SD 40 FOR IM NAILS THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15536378 ↗
• InjuryOct 4, 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 REMOVAL OF HARDWARE DUE TO POSSIBLE INFECTION. UNKNOWN SCREW LENGTHS. NO SURGICAL DELAY WAS THERE. THE PROCEDURE SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. PATIENT CONSEQUENCES WERE UNKNOWN. THIS REPORT IS FOR ONE (1) 5.0 TI LCKNG SCR T25 SD 40 FOR IM NAILS THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15536376 ↗
• InjuryOct 4, 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 REMOVAL OF HARDWARE DUE TO POSSIBLE INFECTION. UNKNOWN SCREW LENGTHS. NO SURGICAL DELAY WAS THERE. THE PROCEDURE SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. PATIENT CONSEQUENCES WERE UNKNOWN. THIS REPORT IS FOR ONE (1) 5.0 TI LCKNG SCR T25 SD 40 FOR IM NAILS THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15536364 ↗
• 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: Ambulation or Postural Difficulties

  MAUDE report 15093796 ↗
• 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: Pain

  MAUDE report 15053320 ↗
• 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 14119454 ↗
• InjuryFeb 4, 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 HARDWARE DUE TO PAIN. THERE WAS NO MALFUNCTION IN HARDWARE NOTED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT INVOLVES ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM FOR IM NAILS. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 13451250 ↗
• 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 40MM FOR IM NAILS. THIS IS REPORT 6 OF 7 FOR (B)(4).

  Patient problems: Necrosis; Unspecified Infection

  MAUDE report 12779356 ↗
• 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 40MM FOR IM NAILS. THIS IS REPORT 3 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Necrosis; Unspecified Infection

  MAUDE report 12779348 ↗
• 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 40MM FOR IM NAILS. THIS REPORT IS 3 OF 13 FOR (B)(4).

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

  MAUDE report 12356680 ↗
• 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 40MM FOR IM NAILS. THIS REPORT IS 5 OF 13 FOR (B)(4).

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

  MAUDE report 12356588 ↗
• 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) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM FOR IM NAILS. THIS IS REPORT 2 OF 6 FOR (B)(4).

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

  MAUDE report 12204509 ↗
• 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 40 FOR IM NAILS. THIS REPORT IS 3 OF 6 FOR (B)(4).

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

  MAUDE report 12199734 ↗
• InjuryJun 29, 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 NAIL REMOVAL WAS PERFORMED AND THE PATIENT WAS CONVERTED TO A BALL JOINT. THE ORIGINAL IMPLANTATION DATE IS UNKNOWN. THE PATIENT AND PROCEDURE OUTCOME ARE UNKNOWN. THIS REPORT IS FOR (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM FOR IM NAILS. THIS IS REPORT 3 OF 3 FOR (B)(4).

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

  MAUDE report 12086701 ↗
• InjuryMay 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6), 2021, PATIENT UNDERWENT REMOVAL OF TITANIUM CANNULATED PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NAIL, TFNA FENESTRATED HELICAL BLADE AND TITANIUM LOCKING SCREW DUE TO PAIN. THE SURGEON IMPLANTED A TOTAL HIP REPLACEMENT. SURGERY WAS SUCCESSFUL AND IMPLANTS WERE REMOVED WITH NO ISSUES. NO PATIENT CONSEQUENCES WERE REPORTED. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM FOR IM NAILS. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 11778328 ↗
• InjuryApr 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT UNDERWENT HARDWARE REMOVAL PROCEDURE DUE TO POSTOPERATIVE PAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 11737986 ↗
• InjuryApr 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT UNDERWENT HARDWARE REMOVAL PROCEDURE DUE TO POSTOPERATIVE PAIN. THIS IS REPORT 2 OF 3 FOR(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 11737985 ↗
• InjuryDec 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) LEFT NAIL 14 X 400MM, 110MM FENESTRATED SCREW, AND TWO (2) DISTAL INTER-LOCKING SCREWS WERE REMOVED DUE TO BONE NON-UNION. PATIENT HAS CANCER. DEVICES WERE ORIGINALLY IMPLANTED ON (B)(6) 2019. IMPLANTS WERE REMOVED SUCCESSFULLY WITHOUT COMPLICATIONS. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM FOR IM NAILS. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11100560 ↗
• InjuryDec 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) LEFT NAIL 14 X 400MM, 110MM FENESTRATED SCREW, AND TWO (2) DISTAL INTER-LOCKING SCREWS WERE REMOVED DUE TO BONE NON-UNION. PATIENT HAS CANCER. DEVICES WERE ORIGINALLY IMPLANTED ON (B)(6) 2019. IMPLANTS WERE REMOVED SUCCESSFULLY WITHOUT COMPLICATIONS. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM FOR IM NAILS. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11100557 ↗
• InjuryAug 18, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT FEMUR REVISION DUE TO NON-UNION AND BROKEN PROXIMAL FEMORAL NAILING SYSTEM (TFNA) LONG NAIL. THE PATIENT'S STATUS WAS GOOD AND A NEW PROXIMAL FEMORAL NAILING SYSTEM (TFNA) WAS IMPLANTED. FRAGMENTS WERE GENERATED FROM THE BROKEN DEVICE AND WERE EASILY REMOVED. PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM FOR IM NAILS. THIS IS REPORT 3 OF 3 FOR (B)(4).

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

  MAUDE report 10420151 ↗
• InjuryJun 2, 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 REVISION OF AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY TO ADDRESS A NON-UNION OF THE MID-SHAFT FEMUR PREVIOUSLY FIXATED WITH A 1 TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL 14MM LONG, 1 UNKNOWN 85MM LAG SCREW AND 2 TITANIUM (TI) LOCKING SCREW WITH T25 STARDRIVE 40MM FOR IM NAILS. THE PREVIOUS SURGERY WAS PERFORMED IN 2017. THERE WAS NO BROKEN HARDWARE PRESENTED, BUT A SUSPECTED INFECTION WAS PRESENT WHICH MAY HAVE CAUSED THE NON-UNION. THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL, UNKNOWN LAG SCREW, AND TITANIUM (TI) LOCKING SCREW WITH T25 STARDRIVE 40MM FOR IM NAILS WERE SUCCESSFULLY REMOVED WITHOUT BREAKAGE. THE SYNTHES RIA SYSTEM WAS USED TO CLEAR THE FEMORAL CANAL OF ANY PRESENT INFECTION. 10CC OF NORIAN WAS THEN IMPLANTED INTO THE PROXIMAL FEMUR WHERE THE PREVIOUS UNKNOWN LAG SCREW SAT. A 9X380 FRN-GT NAIL WAS OPENED AND ANTIBIOTIC CEMENT WAS WRAPPED AROUND THE NAIL. THE NAIL WAS THEN INSERTED INTO THE FEMUR TO ADDRESS THE NON-UNION. THE NAIL WAS LOCKED PROXIMALLY USING ONE 6.5 RECON SCREW AND ONE 5.0 LOCKING SCREW. THE NAIL WAS ALSO DISMALLY LOCKED USING TWO 5.0 INTERLOCKING SCREWS. THE PROCEDURE O

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

  MAUDE report 10109186 ↗
• InjuryJun 2, 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 REVISION AND HARDWARE REMOVAL. THE REVISION SURGERY WAS DUE TO INFECTION AND NON-UNION OF TWO (2) CORTEX SCREWS, ONE (1) TITANIUM CANNULATED TIBIAL NAIL-EX WITH PROXIMAL BEND, FOUR (4) TITANIUM LOCKING SCREW AND ONE (1) TITANIUM END CAP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT'S STATUS IS UNKNOWN. CONCOMITANT DEVICES REPORTED: 3.5 MM CORTEX SCREW SELF-TAPPING 40 MM (PART NUMBER 204.84, LOT UNKNOWN, QUANTITY 1), 3.5 MM CORTEX SCREW SELF-TAPPING 44 MM (PART NUMBER 204.844, LOT UNKNOWN, QUANTITY 1), 10 MM TI CANN TIBIAL NAIL-EX W/PROX BEND 345 MM-STERILE (PART NUMBER 04.034.449S, LOT 22P4336, QUANTITY 1), 5.0 MM TI LOCKING SCREW W/T25 STARDRIVE 34 MM FOR IM NAILS (PART NUMBER 04.005.524, LOT UNKNOWN, QUANTITY 1), 5.0 MM TI LOCKING SCREW W/T25 STARDRIVE 38 MM FOR IM NAILS (PART NUMBER 04.005.528, LOT UNKNOWN, QUANTITY 1), 5.0 MM TI LOCKING SCREW W/T25 STARDRIVE 36 MM FOR IM NAILS (PART NUMBER 04.005.526, LOT UNKNOWN, QUANTITY 1), TI END CAP WITH T40 STARDRIVE 0 MM EXT F/TI TIBIAL NAILS-EX (PART NUMBER 04.004.000, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 5.0 MM TI LOCKING SCREW W/T25 STARDRIVE 40 MM

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

  MAUDE report 10108227 ↗