NA 355.399Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982194954), received between Sep 28, 2020 and Apr 3, 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.

• MalfunctionApr 3, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED DEFECT PRODUCT. THE ITEM WAS BENT. SHIPPING BOX AND ITEM BOX WAS NOT DAMAGED. THERE WAS NO PATIENT INVOLVEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781522 ↗
• MalfunctionMay 7, 2025Material Twisted/Bent; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21975711 ↗
• MalfunctionMay 7, 2025Material Twisted/Bent; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21975667 ↗
• InjuryNov 24, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE UNDERWENT FOR A REVISION SURGERY DUE TO NON-UNION. IT WAS REPORTED THAT IN (B)(6) 2016 THE PATIENT UNDERWENT FOR THE OPEN REDUCTION INTERNAL FIXATION SURGERY FOR RIGHT FEMORAL TROCHANTERIC FRACTURE WITH THE TFNA NAIL. DURING THE REVISION SURGERY ON (B)(6) 2020, IT WAS FOUND THAT THE NAIL HAD BEEN BROKEN UNDER TROCHANTERIC FEMUR. THE SURGEON UNABLE TO REMOVE THE NAIL DUE TO EXTRACTION HOOK COULDN¿T HOLD THE NAIL FIRMLY AND CLOSED THE INCISION. THE REOPERATION WAS SCHEDULE. THE SURGERY WAS COMPLETED WITH 210 MINUTES DELAY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) EXTRACTION HOOK FOR TI CANNULATED NAILS. (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 10896251 ↗
• MalfunctionSep 28, 2020Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING THE INCOMING INSPECTION, AT THE HOSPITAL, IT WAS NOTICED THAT THE INSTRUMENT WAS BENT. THE INSTRUMENT WAS NOT PUT IN USE. NO SURGERY OR PATIENT WAS AFFECTED. THIS REPORT INVOLVES ONE (1) EXTRACTION HOOK FOR TI CANNULATED NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10592847 ↗