NA 357.420Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982196439), received between Oct 9, 2019 and Sep 15, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50781350 ↗
• MalfunctionJul 29, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEMS WERE INSPECTED POST-OP AND WERE FOUND BENT AND FUSED TOGETHER. PATIENT WAS UNHARMED AND PROCEDURE WAS SUCCESSFUL FOR IMPLANT REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22642083 ↗
• MalfunctionAug 12, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A TFNA REMOVAL, THE CONICAL EXTRACTOR WAS USED AND COULD NOT BE UNTHREADED FROM THE NAIL. THE SAME HAPPENED WITH THE HAMMER GUIDE AND MALLETS. ADDITIONALLY, THE REAMERS BROKE IN THE CANALS AND WERE INTRAOPERATIVELY REMOVED BY TAKING OUT THE BALL TIP. THERE WAS A SURGICAL DELAY OF FIVE MINUTES. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE CONICAL EXTRACTION BOLT FOR TROCHANTERIC FIXATION NAILS. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19963634 ↗
• MalfunctionFeb 22, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2022, IT WAS FOUND IN SPD AND NOTICED THE THREADS WERE STRIPPED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. OTHER MEDICAL INTERVENTIONS ARE UNKNOWN. THIS COMPLAINT INVOLVES (1) DEVICES CONICAL EXTRACTION BOLT FOR TFN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13578770 ↗
• InjuryOct 9, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF A TROCHANTERIC FIXATION NAIL (TFN) NAIL DUE TO TOTAL HIP REPLACEMENT. A CONICAL EXTRACTION BOLT AND THE TIP OF A HELICAL BLADE/SCREW EXTRACTOR BROKE WHILE TRYING TO REMOVE THE IM NAIL. IT WAS MENTIONED THAT THE IM NAIL WAS NOT REMOVED FOR A COUPLE OF HOURS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A TWO (2) HOURS SURGICAL DELAY. THE PATIENT STATUS WAS FINE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# / LOT# UNKNOWN, QUANTITY: UNKNOWN); UNKNOWN TFN HELICAL BLADE (PART#/LOT# UNKNOWN, QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) CONICAL EXTRACTION BOLT FOR TROCHANTERIC FIXATION NAILS. THIS IS REPORT IS 2 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9172569 ↗