AGILE NAIL 1 (REF 99-183281)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18054242519041), received between Jul 1, 2020 and Jul 1, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2020Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: 99183281 (GUIDE WIRE WITH OLIVE L980MM D2.8MM), BATCH NUMBER: B1256628, QUANTITY: 1, HOSPITAL NAME: (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2020. BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT'S INFORMATION: NO RESPONSE. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "INTRODUCTION OF OLIVE GUIDE FOR IMPLANT OF AGILE NAIL. WHEN SORTING OUT THE GUIDE, OLIVE KEPT INSIDE FEMUR. IT REVEALS IMPOSSIBLE TO EXTRACT OLIVE WITHOUT OPENING FEMUR. THIS REPRESENTS AN INFECTIOUS RISK". THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (UNRETRIEVED DEVICE FRAGMENT), THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE, THE EVENT DID NOT LEAD TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE, AN ADDITIONAL SURGERY WAS NOT REQUIRED, PRODUCT IS AVAILABLE FOR RETURN, NO INFORMATION WAS PROVIDED ABOUT PATIENT CURRENT HEALTH CONDITIONS. ON JUNE 11, 2020, ORTHOFIX SRL RECEIVED THE FOLLOWING ADDITIONAL INFORMATION: 1). NAME OF THE SURGEON : PR FRANCK ACCADBLED, DR (B)

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 10216634 ↗