NA 04.005.524SRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982085931), received between Jan 9, 2019 and Jan 22, 2024 — classified as 6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2024Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN OSTEOSYNTHESIS FOR A SUBTROCHANTERIC FRACTURE OF THE FEMUR. THE SURGEON DRILLED WITH A RADIOLUCENT DRIVE, MEASURED, AND ATTEMPTED TO INSERT THE LOCKING SCREW. HOWEVER, THE INSERTION OF THE LOCKING SCREW WAS TOO RIGID TO PROCEED, AND THE LOCKING SCREW COULD ONLY BE INSERTED HALFWAY. THE SURGEON PULLED OUT THAT LOCKING SCREW, RE-DRILLED, AND TRIED TO INSERT THE LOCKING SCREW AGAIN, BUT COULD NOT, SO THE SURGEON DECIDED THAT THE LOCKING SCREW APPEARED TO BECOME STRIPPED AND INSERTED ANOTHER LOCKING SCREW. AFTER THAT, THE SURGEON DRILLED CAREFULLY FOR THE OTHER HOLE OF THE NAIL, INSERTED A LOCKING SCREW INTO IT, AND COMPLETED THE SURGERY SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO ADVERSE PATIENT IMPACT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM F/IM NAIL-STER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18553586 ↗
• InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT ORIF SURGERY FOR FEMORAL TROCHANTERIC FRACTURE WITH PFNA NAIL, BLADE, END CAP AND LOCKING SCREW. ON AN UNKNOWN DATE ON (B)(6) 2023, E. COLI INFECTION WAS CONFIRMED. REOPERATION WAS PERFORMED ON (B)(6) 2023. THE BONE UNION APPEARED TO HAVE BEEN ACHIEVED BUT WAS REPLACED TO PREVENT RE-FRACTURE. END CAPS AND LOCKING SCREWS WERE NOT INSERTED TO REFLUX THE CHEMICAL SOLUTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM F/IM NAIL-STER. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 17367281 ↗
• MalfunctionNov 7, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING FINAL HAND TIGHTENING OF THE SCREW IN QUESTION IMPLANTED THROUGH A SHORT TFNA AIMING ARM, THE RESIDENT SNAPPED THE HEAD OFF OF THE SCREW AGAINST THE LATERAL CORTEX. THE SCREW BROKE AT THE VERY BEGINNING OF THE SCREW HEAD/SHAFT JUNCTION. THE SURGEON SUCCESSFULLY REMOVED THE FRAGMENT OF THE SCREW HEAD FROM THE PATIENT. THE SHAFT REMAINED IN PLACE ACROSS BOTH CORTICES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY FOR REMOVING THE BROKEN SCREW HEAD. A LARGER INCISION WAS REQUIRED TO REMOVE THE FRAGMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM F/IM NAIL-STER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15744702 ↗
• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2021, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION WITH THE TROCHANTERIC FIXATION NAIL- ADVANCED FOR THE FRACTURE OF THE DIAPHYSEAL FEMUR. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, SECONDARY FRACTURE HAD OCCURRED. A TFNA FENESTRATED HELICAL BLADE 90MM ¿ STERILE, TFNA FEMORAL NAIL Ø11 125° L200 TIMO15, LOCKSCREW Ø5 L34 F/NAILS TAN- LIGHT GREEN, AND A TFNA END CAP EXTENSION 0 TAN WERE USED DURING THE PROCEDURE. ON (B)(6), 2022, THE REVISION SURGERY WAS PERFORMED TO REMOVE THE TROCHANTERIC FIXATION NAIL- ADVANCED AND FIX THE FRACTURE WITH A LONG GAMMA NAIL AND SCREWS. ACCORDING TO THE SURGEON, THIS EVENT WAS CAUSED BY A TECHNICAL ERROR DUE TO POOR IMPLANT INSERTION POINT, NOT PRODUCT MALFUNCTION. THE SURGEON THOUGHT THAT THE PATIENT HAD NOT FALLEN. THE SURGEON GUESSED THAT THE SECONDARY FRACTURE MAY BE A STRESS FRACTURE BECAUSE THE INSERTION POINT WAS POSTERIOR, AND THE TIP OF NAIL WAS HITTING THE ANTERIOR CORTICAL BONE. NO FURTHER INFORMATION IS AVAILABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME IS REPORTED AS

  Patient problems: Bone Fracture(s)

  MAUDE report 14254598 ↗
• InjuryApr 15, 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 HARDWARE REMOVAL OF THE TROCHANTERIC FIXATION NAIL ADVANCED FROM THE PATIENT'S RIGHT HIP. BASED ON XRAYS IT WAS DETERMINED THE HELICAL BLADE WAS CUTTING THROUGH THE FEMORAL HEAD. THE PATIENT'S INTERTROCHANTERIC FRACTURE WAS HEALED. THE ORIGINAL IMPLANT WAS ON (B)(6) 2020. THE HARDWARE REMOVAL WAS SUCCESSFULLY COMPLETED WITHOUT DELAY. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) 5.0 TI LCKNG SCREW T25 SD 34 F/IM NAIL-S. THIS REPORT IS 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11670577 ↗
• InjuryAug 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A PROCEDURE TO HAVE THE TFNA SYSTEM IMPLANTED. DURING THE PROCEDURE, THE SURGEON INTRODUCED THE NAIL, PASSED THE TRACTION SCREW, LOCKED IT AND WHEN THE COMPRESSION WAS MADE, THE FRACTURE IS DEVASTATED. THE SURGEON PERFORMED AUGMENTATION IN WHICH THE CEMENT CAME OUT AND WENT TO THE FOCUS OF THE FRACTURE WITHOUT LEAVING IT. THERE WAS PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM F/IM NAIL-STER. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10462230 ↗
• InjuryMar 21, 2019Device-Device Incompatibility; Device-Device Incompatibility

  WHEN ATTEMPTING TO SCREW THE AIMING ARM INTO THE INSERTION HANDLE, IT FELT CROSS THREADED. IT DID NOT FEEL SMOOTH GOING INTO THE HOLE THREADS TO CONNECT THE TWO PIECES.

  Patient problems: No Code Available

  MAUDE report 8440908 ↗
• InjuryJan 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT HARDWARE REMOVAL DUE TO INFECTION OF THE HIP. DURING THE REMOVAL, THE TITANIUM TROCHANTERIC FIXATION NAIL SCREW, TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL, AND TITANIUM LOCKING SCREW WITH T25 STARDRIVE WERE REMOVED. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR ONE (1) TI LOCKING SCREW. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8232422 ↗