NA 04.005.520SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982085894), received between Jan 22, 2024 and Aug 25, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT PRIMARY SURGERY FOR FEMORAL TROCHANTERIC FRACTURE WITH TFNA AT ANOTHER HOSPITAL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. POSTOPERATIVELY, THE PATIENT SUSTAINED A FRACTURE DISTAL TO THE TFNA. THEREFORE, AN ORIF SURGERY FOR A DISTAL FRACTURE IS SCHEDULED TO BE PERFORMED AT THIS HOSPITAL. AT THAT TIME, THERE IS A POSSIBILITY THAT THE DISTAL LOCKING SCREW OF THE TFNA MAY INTERFERE WITH THE PLATE PLACEMENT AREA, SO IT IS POSSIBLE THAT ONLY THE SCREW WILL BE REMOVED. IT IS UNKNOWN WHEN REVISION WILL OCCUR. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 22889440 ↗
• MalfunctionJan 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 05-JANUARY-2024, THE PATIENT UNDERWENT AN ORIF FOR A FEMUR FRACTURE. AFTER A NAIL WAS INSERTED, THE PROXIMAL AREA OF THE NAIL WAS FIXED PROPERLY, AND A FIRST SCREW WAS ALSO PROPERLY INSERTED INTO THE DISTAL AP HOLE. HOWEVER, WHEN AN ATTEMPT WAS MADE TO INSERT A SECOND SCREW INTO THE ML STATIC HOLE, THE TIP OF THE SCREW COULD NOT BE CAPTURED BEYOND THE CONTRALATERAL CORTEX AND BECAME IDLED. THE SURGEON TRIED TO INSERT THE SCREW AGAIN WHILE APPLYING STRONG AXIAL PRESSURE, BUT IT DID NOT GO IN AT ALL. THEREFORE, ANOTHER SCREW WITH THE SAME SIZE WAS ATTEMPTED TO BE INSERTED TO THAT HOLE, BUT IT WAS A SAME NEGATIVE OUTCOME. AN INSERTION TRIAL FOR THAT HOLE WAS PAUSED. AND THEN, THE SURGEON INSERTED SCREWS INTO OTHER 2 HOLES, AND EACH OF THE HOLES WERE SUCCESSFULLY FIXED. THE CORRELATION BETWEEN THE BURR HOLE AND THE NAIL HOLE, WHERE THE SCREW COULD NOT BE INSERTED, DID NOT APPEAR TO BE SIGNIFICANTLY MISALIGNED WHEN IT WAS OBSERVED BY AN IMAGE INTENSIFIER. INCIDENTALLY, THE SURGEON TRIED INSERTION OF THE SCREWS INTO THE ML STATIC HOLE ONCE AGAIN, BUT HE COULDN'T. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A SU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18554144 ↗
• MalfunctionJan 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN ORIF FOR A FEMUR FRACTURE. AFTER A NAIL WAS INSERTED, THE PROXIMAL AREA OF THE NAIL WAS FIXED PROPERLY, AND A FIRST SCREW WAS ALSO PROPERLY INSERTED INTO THE DISTAL AP HOLE. HOWEVER, WHEN AN ATTEMPT WAS MADE TO INSERT A SECOND SCREW INTO THE ML STATIC HOLE, THE TIP OF THE SCREW COULD NOT BE CAPTURED BEYOND THE CONTRALATERAL CORTEX AND BECAME IDLED. THE SURGEON TRIED TO INSERT THE SCREW AGAIN WHILE APPLYING STRONG AXIAL PRESSURE, BUT IT DID NOT GO IN AT ALL. THEREFORE, ANOTHER SCREW WITH THE SAME SIZE WAS ATTEMPTED TO BE INSERTED TO THAT HOLE, BUT IT WAS A SAME NEGATIVE OUTCOME. AN INSERTION TRIAL FOR THAT HOLE WAS PAUSED. AND THEN, THE SURGEON INSERTED SCREWS INTO OTHER 2 HOLES, AND EACH OF THE HOLES WERE SUCCESSFULLY FIXED. THE CORRELATION BETWEEN THE BURR HOLE AND THE NAIL HOLE, WHERE THE SCREW COULD NOT BE INSERTED, DID NOT APPEAR TO BE SIGNIFICANTLY MISALIGNED WHEN IT WAS OBSERVED BY AN IMAGE INTENSIFIER. INCIDENTALLY, THE SURGEON TRIED INSERTION OF THE SCREWS INTO THE ML STATIC HOLE ONCE AGAIN, BUT HE COULDN'T. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A SURGIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18554143 ↗