NA 04.005.524Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10886982085924), received between Jan 3, 2018 and Apr 10, 2023 — classified as 19 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 16, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryApr 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THE PATIENT UNDERWENT HARDWARE REMOVAL DEEP DUE TO RIGHT FEMUR PAINFUL HARDWARE. THE PLATE SCREWS AND STIMULATOR BODIES WERE REMOVED. THE STIMULATOR ELECTRODES WERE ENCASED IN BONE AND WERE NOT EXTRACTED. THIS REPORT IS FOR ONE (1) 5.0 TI LCKNG SCR T25 SD 34 FOR IM NAILS. THIS IS REPORT 12 OF 12 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 16709685 ↗
• 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 14119443 ↗
• 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 34MM FOR IM NAILS. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 13451211 ↗
• InjuryJan 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A NONUNION FROM A PREVIOUS SURGERY IN THE FEMORAL SHAFT/PROXIMAL FEMUR WAS DISCOVERED. THE SURGEON REMOVED A TFNA DEVICE, USED THE RIA TO COLLECT BONE GRAFT, AND THEN INSERTED A 95 DEGREE BLADE PLATE TO CORRECT THE NONUNION. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) 5.0 TI LCKNG SCR T25 SD 34 FOR IM NAILS THIS IS REPORT 3 OF 5 FOR PC-(B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 13253451 ↗
• InjuryJan 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A NONUNION FROM A PREVIOUS SURGERY IN THE FEMORAL SHAFT/PROXIMAL FEMUR WAS DISCOVERED. THE SURGEON REMOVED A TFNA DEVICE, USED THE RIA TO COLLECT BONE GRAFT, AND THEN INSERTED A 95 DEGREE BLADE PLATE TO CORRECT THE NONUNION. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) 5.0 TI LCKNG SCR T25 SD 34 FOR IM NAILS. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 13253447 ↗
• 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 34MM FOR IM NAILS. THIS IS REPORT 2 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Necrosis; Unspecified Infection

  MAUDE report 12779335 ↗
• 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 1 OF 6 FOR (B)(4).

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

  MAUDE report 12316229 ↗
• InjuryJul 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, PATIENT UNDERWENT A REVISION OF A TIBIAL SHAFT FRACTURE HYPERTROPHIC NON-UNION. THE HARDWARE WAS REMOVED WITHOUT COMPLICATIONS AND REVISED. ALL IMPLANTS WERE INTACT UPON REMOVAL NOTHING WAS BROKEN. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT WAS DOING FINE POST-OPERATIVELY. THERE WERE NO COMORBIDITIES FOR THE PATIENT. THE ORIGINAL DATE OF SURGERY WAS ON THE MONTH OF (B)(6) 2019. THIS REPORT IS FOR (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM FOR IM NAILS. THIS IS REPORT 1 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12116472 ↗
• InjuryJul 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, PATIENT UNDERWENT A REVISION OF A TIBIAL SHAFT FRACTURE HYPERTROPHIC NON-UNION. THE HARDWARE WAS REMOVED WITHOUT COMPLICATIONS AND REVISED. ALL IMPLANTS WERE INTACT UPON REMOVAL NOTHING WAS BROKEN. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT WAS DOING FINE POST-OPERATIVLELY. THERE WERE NO COMORBIDITIES FOR THE PATIENT. THE ORIGINAL DATE OF SURGERY WAS ON THE MONTH OF (B)(6) 2019. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM FOR IM NAILS. THIS IS REPORT 2 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12116470 ↗
• InjuryJan 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS ALSO REPORTED THAT THE PATIENT WAS CONVERTED TO TOTAL HIP PROSTHESIS DUE TO NONUNION AFTER 6 MONTHS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11237683 ↗
• InjuryJul 7, 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 REMOVAL OF THE EXPERT TIBIAL NAIL, FIVE (5) 5.0MM LOCKING SCREWS AND TWO (2) 4.0MM CANNULATED SCREWS . THE REASON FOR THE REMOVAL OF THE IMPLANTS WAS DUE TO NON-UNION AND THE PATIENT ANATOMY FELL INTO VALGUS FROM IMPLANT FAILURE. DURING THE REVISION PROCEDURE, ALL THE ORIGINAL IMPLANTS WERE REMOVED AND THE PATIENT WAS REVISED TO A NEW TIBIAL NAIL AND FIBULA LOCKING PLATE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM FOR IM NAILS. THIS IS REPORT 7 OF 8 FOR (B)(4).

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

  MAUDE report 10240330 ↗
• InjuryJul 7, 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 REMOVAL OF THE EXPERT TIBIAL NAIL, FIVE (5) 5.0 MM LOCKING SCREWS AND TWO (2) 4.0 MM CANNULATED SCREWS . THE REASON FOR THE REMOVAL OF THE IMPLANTS WAS DUE TO NON-UNION AND THE PATIENT ANATOMY FELL INTO VALGUS FROM IMPLANT FAILURE. DURING THE REVISION PROCEDURE, ALL THE ORIGINAL IMPLANTS WERE REMOVED AND THE PATIENT WAS REVISED TO A NEW TIBIAL NAIL AND FIBULA LOCKING PLATE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 5.0 MM TI LOCKING SCREW W/T25 STARDRIVE 34 MM FOR IM NAILS. THIS IS REPORT 6 OF 8 FOR (B)(4).

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

  MAUDE report 10240267 ↗
• InjuryJul 7, 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 REMOVAL OF THE EXPERT TIBIAL NAIL, FIVE (5) 5.0MM LOCKING SCREWS AND TWO (2) 4.0MM CANNULATED SCREWS. THE REASON FOR THE REMOVAL OF THE IMPLANTS WAS DUE TO NON-UNION AND THE PATIENT ANATOMY FELL INTO VALGUS FROM IMPLANT FAILURE. DURING THE REVISION PROCEDURE, ALL THE ORIGINAL IMPLANTS WERE REMOVED AND THE PATIENT WAS REVISED TO A NEW TIBIAL NAIL AND FIBULA LOCKING PLATE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM FOR IM NAILS. THIS IS REPORT 5 OF 8 FOR (B)(4).

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

  MAUDE report 10240232 ↗
• InjuryJul 7, 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 REMOVAL OF THE EXPERT TIBIAL NAIL, FIVE (5) 5.0MM LOCKING SCREWS AND TWO (2) 4.0MM CANNULATED SCREWS. THE REASON FOR THE REMOVAL OF THE IMPLANTS WAS DUE TO NON-UNION AND THE PATIENT ANATOMY FELL INTO VALGUS FROM IMPLANT FAILURE. DURING THE REVISION PROCEDURE, ALL THE ORIGINAL IMPLANTS WERE REMOVED AND THE PATIENT WAS REVISED TO A NEW TIBIAL NAIL AND FIBULA LOCKING PLATE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM FOR IM NAILS. THIS IS REPORT 4 OF 8 FOR (B)(4).

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

  MAUDE report 10240194 ↗
• InjuryJul 7, 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 REMOVAL OF THE EXPERT TIBIAL NAIL, FIVE (5) 5.0MM LOCKING SCREWS AND TWO (2) 4.0MM CANNULATED SCREWS . THE REASON FOR THE REMOVAL OF THE IMPLANTS WAS DUE TO NON-UNION AND THE PATIENT ANATOMY FELL INTO VALGUS FROM IMPLANT FAILURE. DURING THE REVISION PROCEDURE, ALL THE ORIGINAL IMPLANTS WERE REMOVED AND THE PATIENT WAS REVISED TO A NEW TIBIAL NAIL AND FIBULA LOCKING PLATE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM FOR IM NAILS. THIS IS REPORT 2 OF 8 FOR (B)(4).

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

  MAUDE report 10240076 ↗
• 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: 3.5MM CORTEX SCREW SELF-TAPPING 40MM (PART NUMBER 204.84, LOT UNKNOWN, QUANTITY 1), 3.5MM CORTEX SCREW SELF-TAPPING 44MM (PART NUMBER 204.844, LOT UNKNOWN, QUANTITY 1), 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 345MM-STERILE (PART NUMBER 04.034.449S, LOT 22P4336, QUANTITY 1), 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM FOR IM NAILS (PART NUMBER 04.005.530, LOT UNKNOWN, QUANTITY 1), 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM FOR IM NAILS (PART NUMBER 04.005.528, LOT UNKNOWN, QUANTITY 1), 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM FOR IM NAILS (PART NUMBER 04.005.526, LOT UNKNOWN, QUANTITY 1), TI END CAP WITH T40 STARDRIVE 0MM EXT F/TI TIBIAL NAILS-EX (PART NUMBER 04.004.000, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM FOR IM NAILS.

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

  MAUDE report 10108224 ↗
• InjuryApr 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, PATIENT UNDERWENT REMOVAL OF ONE (1) TITANIUM CANNULATED PROXIMAL FEMORAL NAILING SYSTEM (TFNA), ONE (1) TITANIUM LOCKING SCREW, ONE (1) TFNA HELICAL BLADE AND ONE (1) TFNA END CAP BECAUSE THE FEMUR BROKE BELOW WHERE THESE IMPLANTS SAT. IMPLANTS WERE ORIGINALLY IMPLANTED ON (B)(6) 2020. SHE WAS INITIALLY SEEN FOR AN INTERTROCHANTERIC HIP FRACTURE. ALL IMPLANTS ARE SUCCESSFULLY REMOVED AND WERE REVISED TO A LONG TFNA AND WERE ALSO AUGMENTED FIXATION WITH A TRAUMA CEMENT. THE PATIENT OUTCOME WAS SUCCESSFUL WITH NO CONCERNS. CONCOMITANT DEVICES REPORTED: 11MM/130 DEG TI CANN TFNA 170MM ¿ STERILE (PART NUMBER 04.037.142S, LOT UNKNOWN, QUANTITY 1), TFNA HELICAL BLADE 90MM (PART NUMBER 04.038.290, LOT UNKNOWN, QUANTITY 1), END CAPS: TFNA (UNKNOWN PART NUMBER, UNKNOWN LOT, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM FOR IM NAILS. THIS IS REPORT 2 OF 4 FOR (B)(4).

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

  MAUDE report 9953384 ↗
• InjuryMar 31, 2020No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT REMOVAL OF TITANIUM CANNULATED TIBIAL NAIL, TITANIUM LOCKING SCREW 42MM AND TITANIUM LOCKING SCREW 34MM DUE TO HYPERTROPHIC NONUNION 15 MONTHS POSTOPERATIVELY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM FOR IM NAILS. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 9904211 ↗
• InjuryJan 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A SYNTHES 11MM TITANIUM (TI) CANNULATED TIBIAL NAIL AND FIVE (5) LOCKING SCREWS TO TREAT AN UNKNOWN TIBIA FRACTURE ON AN UNKNOWN DATE. POSTOPERATIVELY, ON AN UNKNOWN DATE, IT WAS IDENTIFIED THAT THERE WAS A NON-UNION OF THE FRACTURE AND ON (B)(6) 2017, THE PATIENT WAS RETURNED TO THE OPERATING ROOM WHERE THE NAIL AND SCREWS WERE REMOVED AND THE PATIENT WAS REVISED USING A NEW TIBIAL NAIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO SURGICAL DELAY WAS NOTED. PATIENT STATUS IS UNKNOWN. (B)(4).

  Patient problems: Impaired Healing; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7161395 ↗