NA 04.005.530SRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982085993), received between Mar 30, 2020 and Feb 12, 2024 — classified as 8 injuries, 2 malfunctions.

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2024Difficult to Advance; Difficult to Advance

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT OSTEOSYNTHESIS WITH TFNA IMPLANT FOR A SUBTROCHANTERIC FRACTURE. DURING THE SURGERY, THE DISTAL LOCKING SCREW COULD NOT BE INSERTED BEYOND THE CONTRALATERAL CORTEX. THE SURGEON DRILLED AGAIN MULTIPLE TIMES, CAREFULLY CHECKING THE INSERTION DIRECTION, BUT THERE WAS NO IMPROVEMENT. ANOTHER SCREW OF THE SAME TYPE WAS USED AND INSERTION WAS SUCCESSFUL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM F/IM NAIL-STER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18684511 ↗
• InjuryFeb 11, 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 UNDERWENT HARDWARE REMOVAL OF TFNA NAIL, LAG SCREW AND DISTAL SCREWS. TRANSITIONED/REVISED PATIENT TO A TOTAL HIP ARTHROPLASTY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT INVOLVES (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM F/IM NAIL-STER. THIS IS REPORT 4 OF 4 FOR (B)(4).

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

  MAUDE report 13515164 ↗
• InjuryFeb 11, 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 UNDERWENT HARDWARE REMOVAL OF TFNA NAIL, LAG SCREW AND DISTAL SCREWS. TRANSITIONED/REVISED PATIENT TO A TOTAL HIP ARTHROPLASTY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT INVOLVES (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM F/IM NAIL-STER. THIS IS REPORT 3 OF 4 FOR (B)(4).

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

  MAUDE report 13515110 ↗
• MalfunctionNov 19, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE, IT WAS NOTED WHILE INSERTING THE SCREWS, THE RESIDENT SURGEON DID NOT RECEIVE GOOD PURCHASE IN THE BONE. THE SCREW WAS EXCHANGED FOR A LONGER SCREW THAT ALSO DID NOT HAVE PURCHASE, BUT WAS ULTIMATELY ACCEPTED. THE PATIENT WAS OSTEOPOROTIC. NO ADVERSE EVENT OCCURRED AND NO BROKEN FRAGMENTS. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM F/IM NAIL-STER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12846353 ↗
• InjuryOct 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 RE-OPERATION DUE TO BEING NON-COMPLIANT WITH THE PHYSICIAN'S INSTRUCTIONS WHICH RESULTED IN A NON-UNION FRACTURE. TITANIUM CANNULATED TIBIAL NAIL AND FOUR (4) LOCKING SCREWS WILL BE REMOVED. THERE WAS PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM F/IM NAIL-STER THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12666274 ↗
• InjuryJun 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN ORTHOPEDIC PROCEDURE, AFTER THE TFNA IMPLANTED ON (B)(6) 2021, THE FEMUR WAS BROKEN BELOW DISTAL INTERLOCKING SCREW IN NAIL. NAIL, LAG SCREW, AND DISTAL INTERLOCKING SCREW WERE REMOVED ON (B)(6) 2021 AND SWAPPED OUT WITH NEW TFNA EXCHANGE NAIL, LAG SCREW AND NEW INTERLOCKING SCREW DISTALLY. THE PROCEDURE SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) 5.0 TI LCKNG SCREW T25 SD 40 F/IM NAIL-S. THIS REPORT IS 3 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 12060573 ↗
• InjuryFeb 3, 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 REMOVAL DUE TO THE MALREDUCTION OF THE ORIGINAL SURGERY. THE ORIGINAL SURGERY WAS DONE AT THE END OF (B)(6) 2020. THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) FEMORAL NAIL, FEMORAL NECK SCREWS, PERFORATED AND 5.0MM TI LOCKING SCREW WERE REMOVED SUCCESSFULLY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM F/IM NAIL-STER. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Malunion of Bone

  MAUDE report 11275250 ↗
• InjuryNov 24, 2020Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2020, PATIENT UNDERWENT REMOVAL OF FEMORAL NAIL AND WAS CONVERTED TO TOTAL HIP DUE TO CUT OUT. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM F/IM NAIL-STER. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 10896873 ↗
• InjuryJun 18, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A FEMUR FRACTURE PROCEDURE USING RETROGRADE FEMORAL NAIL. DURING THE PROCEDURE, AN INCORRECT PROTECTION SLEEVE WAS USED AND THE SCREWS MISSED THE NAIL LEAVING A SMALL HOLE IN THE NAIL. THE SCREWS WERE REMOVED. THE SURGEON INSERTED THE CORRECT PROTECTION SLEEVE, DRILLED AND INSERTED SCREWS. THERE WAS A FIVE (5) MINUTE SURGICAL DELAY. THE PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO PATIENT HARM. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM F/IM NAIL-STER. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Injury

  MAUDE report 10171983 ↗
• InjuryMar 30, 2020Break; Break

  CONCOMITANT DEVICES: 5.0MM TI LOCKING SCREW 40MM (PART: 04.005.530S, LOT: H218356, QUANTITY: 1), TFNA FENESTRATED HELICAL BLADE (PART: 04.038.400S, LOT: H797967, QUANTITY: 1).

  Patient problems: Bone Fracture(s); Foreign Body In Patient; Pain

  MAUDE report 9897975 ↗