NA 04.005.522SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982085917), received between Sep 21, 2018 and Jan 23, 2026 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Device-Device Incompatibility

  IT WAS NOT POSSIBLE TO UNLOCK THE SYSTEM TO REMOVE IT.

  Patient problems: Insufficient Information

  MAUDE report 24168165 ↗
• InjuryNov 2, 2022Adverse 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) 2022, THE PATIENT UNDERWENT THE SURGERY FOR CERVICAL BASE FRACTURE WITH THE PRODUCTS IN QUESTION. THE PATIENT HAD BEEN ABLE TO UNDERGO AN EXTRAMEDULLARY REPAIR, BUT WAS SHIFTED TO INTRAMEDULLARY AFTER SURGERY, AND IS NOW ON THE VERGE OF AN ENDOPROSTHETIC CUTOUT. AN ARTIFICIAL HEAD REPLACEMENT WAS PERFORMED ON (B)(6) 2022. THE CAUSE IS UNKNOWN BECAUSE NO POSTOPERATIVE CT WAS TAKEN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 32MM F/IM NAIL-STER. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 15715797 ↗
• InjuryAug 26, 2022Migration; Migration

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE ORIF SURGERY FOR TROCHANTERIC FRACTURE OF FEMUR WITH THE TFNA LONG IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. A REVISION SURGERY WAS PLANNED FOR (B)(6) 2022, THE TFNA LONG IMPLANTS WILL BE REMOVED AND REPLACED WITH BHA. THE DETAILS OF THE DEFECT ARE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 32MM F/IM NAIL-STER. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15302527 ↗
• InjuryAug 26, 2022Migration; Migration

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE ORIF SURGERY FOR TROCHANTERIC FRACTURE OF FEMUR WITH THE TFNA LONG IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. A REVISION SURGERY WAS PLANNED FOR (B)(6) 2022, THE TFNA LONG IMPLANTS WILL BE REMOVED AND REPLACED WITH BHA. THE DETAILS OF THE DEFECT ARE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 32MM F/IM NAIL-STER. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15302497 ↗
• MalfunctionNov 5, 2018Failure to Cut; Difficult to Advance; Failure to Cut; Difficult to Advance

  IT WAS REPORTED THAT DURING A TIBIAL NAIL CASE PROCEDURE ON (B)(6) 2018, THE FULLY THREADED NON-SELF TAPPING SCREW DID NOT GO INTO THE NAIL. THE SURGEON TRIED SEVERAL TIMES TO GET THE TITANIUM (TI) LOCKING SCREW TO GO IN, THEN PULLED IT OUT AND NOTICED THAT IT WAS NOT A SELF-TAPPING SCREW WHICH THEY NORMALLY USE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF 5 MINUTES. PATIENT STATUS WAS GOOD. THIS REPORT IS FOR A 5.0MM TI LOCKING SCREW 32MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8039372 ↗
• InjurySep 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT DURING THE REMOVAL PROCEDURE, SCREWS WERE REMOVED AND NO ADDITIONAL DEVICES WERE IMPLANTED.

  Patient problems: No Code Available; Pain

  MAUDE report 7898225 ↗
• InjurySep 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT DURING THE REMOVAL PROCEDURE, SCREWS WERE REMOVED AND NO ADDITIONAL DEVICES WERE IMPLANTED.

  Patient problems: No Code Available; Pain

  MAUDE report 7898184 ↗