ORTHOFIX 1 (REF 99-709245)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 18059015373653), received between Sep 11, 2024 and Sep 11, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Sep 24, 2024Open, Classified

   Retrospective; Their is the potential that implantable intramedullary lengthening nails may bend at the distal tail during insertion resulting in having to be replaced.

   Z-1977-2025 · Root cause: Use error · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2024Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6) HOSPITAL, SURGEON'S NAME: DR. (B)(6), DATE OF INITIAL SURGERY: ON (B)(6) 2024, BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR, SURGERY DESCRIPTION: CORRECTION, PATIENT INFORMATION: 8-YEAR-OLD, PATIENT MEDICAL HISTORY: PATIENT WHO HAD PREVIOUSLY UNDERGONE MULTIPLE SURGERIES FOR OSTEOMYELITIS RESULTING IN BONE LOSS FROM. THE DISTAL FEMUR AND GROWTH ARREST. PATIENT ARRIVED IN THE OR WITH TWO STAINLESS STEEL PLATES ON THE FEMUR THAT HAD TO BE REMOVED PRIOR TO IMPLANTING THE NAIL. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM EVENT DESCRIPTION: FIRST NAIL: DURING REDUCTION MANEUVERS TO IMPLANT THE NAIL, A BEND IN THE DISTAL PORTION OF THE NAIL WAS OBSERVED ON FLUOROSCOPY. NAIL HAD BENT AFTER CONTACTING LATERAL CORTEX JUST DISTAL OF OSTEOTOMY. BEND WAS OBSERVED ON THE LENGTHENING PORTION OF THE NAIL AND APPEARED TO BE BENT THROUGH THE MOST PROXIMAL OF THE 3 DISTAL SCREW HOLES. SURGEON DECIDED TO REMOVE THIS NAIL AND REPLACE IT WITH THE SAME SIZE NAIL. NAIL WAS REMOVED WITHOUT COMPLICATION. SECOND NAIL: THE SAME SIZE NAIL WAS OPENED AND LOADED ONTO THE

  Patient problems: Failure of Implant

  MAUDE report 20192153 ↗
• InjurySep 11, 2024Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6) HOSPITAL, SURGEON'S NAME: DR. (B)(6), DATE OF INITIAL SURGERY: ON (B)(6)2024, BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR, SURGERY DESCRIPTION: CORRECTION, PATIENT INFORMATION: 8-YEAR-OLD. PATIENT MEDICAL HISTORY: PATIENT WHO HAD PREVIOUSLY UNDERGONE MULTIPLE SURGERIES FOR OSTEOMYELITIS RESULTING IN BONE LOSS FROM THE DISTAL FEMUR AND GROWTH ARREST. PATIENT ARRIVED IN THE OR WITH TWO STAINLESS STEEL PLATES ON THE FEMUR THAT HAD TO BE REMOVED PRIOR TO IMPLANTING THE NAIL. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM EVENT DESCRIPTION: FIRST NAIL: DURING REDUCTION MANEUVERS TO IMPLANT THE NAIL, A BEND IN THE DISTAL PORTION OF THE NAIL WAS OBSERVED ON FLUOROSCOPY. NAIL HAD BENT AFTER CONTACTING LATERAL CORTEX JUST DISTAL OF OSTEOTOMY. BEND WAS OBSERVED ON THE LENGTHENING PORTION OF THE NAIL AND APPEARED TO BE BENT THROUGH THE MOST PROXIMAL OF THE 3 DISTAL SCREW HOLES. SURGEON DECIDED TO REMOVE THIS NAIL AND REPLACE IT WITH THE SAME SIZE NAIL. NAIL WAS REMOVED WITHOUT COMPLICATION. SECOND NAIL: THE SAME SIZE NAIL WAS OPENED AND LOADED ONTO THE JI

  Patient problems: Failure of Implant

  MAUDE report 20192062 ↗