FITBONE TAA SYSTEM 1 (REF 60001764)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 18053340344678), received between Apr 23, 2025 and Aug 31, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Mechanical Jam” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  Received information of an issue during implantation of a Fitbone nail. As per reporter, during distal screw locking, the maximum available Orthofix 4.0 mm locking screw was insufficient to achieve both secure fixation and maintain transport mechanism functionality. The surgeon implanted a third-party 4.0mm Ø Steinman-Pin (steel). Allegedly, this led to a surgery delay of 60-90 minutes.The patient is stable and in good health. The receiver and control unit have been tested positive after implantation.No allegation of product malfunction was reported by the user.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50515262 ↗
• InjuryAug 20, 2025Mechanical Jam; Mechanical Jam

  AS PER REPORTER, DURING TREATMENT FOR FEMUR LENGTHENING, THE FITBONE NAIL STOPPED LENGTHENING. PATIENT UNDERWENT A REVISION PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 22847493 ↗
• InjuryAug 14, 2025Mechanical Problem; Mechanical Jam; Mechanical Problem; Mechanical Jam

  RECEIVED INFORMATION STATING THAT A FITBONE NAIL STOPPED WORKING DURING TREATMENT. TWO RETROGRADE LATERAL FEMORAL FITBONES WERE IMPLANTED ON (B)(6) AT (B)(6) HOSPITAL. TWO WEEKS LATER AND AFTER 1,5CM, THE RIGHT NAIL WAS NO LONGER ADVANCING. ON (B)(6), A REVISION SURGERY WAS PERFORMED TO TRY TO RESTART THE NAIL REPLACING THE RECEIVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22802397 ↗
• InjuryAug 14, 2025Mechanical Problem; Mechanical Jam; Mechanical Problem; Mechanical Jam

  RECEIVED INFORMATION STATING THAT A FITBONE NAIL STOPPED WORKING DURING TREATMENT. TWO RETROGRADE LATERAL FEMORAL FITBONES WERE IMPLANTED ON 27 JUNE AT STRASBOURG UNIVERSITY HOSPITAL. TWO WEEKS LATER AND AFTER 1, 5CM, THE RIGHT NAIL WAS NO LONGER ADVANCING. ON 25 JULY, A REVISION SURGERY WAS PERFORMED TO TRY TO RESTART THE NAIL REPLACING THE RECEIVER. AS THE NAIL WAS NOT WORKING, ON 5 AUGUST THE NAIL WAS CHANGED WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22802396 ↗
• InjuryApr 23, 2025Break; Material Integrity Problem; Break; Material Integrity Problem

  RECEIVED INFORMATION THAT A FITBONE NAIL BROKE DURING TREATMENT. MANUFACTURER REF: (B)(4). DISTRIBUTOR REF: (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21888681 ↗