Ankle Compression Nailing System 1 (REF 99-T770005)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18033509859113), received between Mar 18, 2019 and Mar 18, 2019 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 18, 2019Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME:(B)(6). SURGEON NAME: DR. (B)(6). DATE OF INITIAL SURGERY: ON (B)(6) 2018. BODY PART TO WHICH DEVICE WAS APPLIED: ANKLE/CALF. SURGERY DESCRIPTION: UNAVAILABLE. PATIENT INFORMATION: 50 YEAR OLD, MALE. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "THE END CAP FROM THE NAIL DISENGAGED AND THE CALF SCREW MOVED". THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT. THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE. AN ADDITIONAL SURGERY WAS NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. COPIES OF THE X-RAY IMAGES ARE AVAILABLE. PATIENT CURRENT HEALTH CONDITION: UNAVAILABLE. ON (B)(6) 2019, ORTHOFIX SRL RECEIVED THE FOLLOWING ADDITIONAL INFORMATION: PT IS COMPLIANT AND THERE ARE NO ISSUES WITH THE END CAP. THE END CAP REMAINS IMPLANTED SO IT WILL NOT RETURN FOR ANALYSIS. MANUFACTURER REFERENCE NUMBER: (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8427572 ↗