Ankle Compression Nailing System 1 (REF 99-T770010)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18033509859120), received between Mar 6, 2019 and Mar 6, 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. 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.

• MalfunctionMar 6, 2019Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: - PRODUCT CODE: AHN LOCKING END CAP CODE UNKNOWN, - BATCH NUMBER: UNKNOWN, - QUANTITY: 1, - HOSPITAL NAME: UNKNOWN, - SURGEON NAME: (B)(6) - DATE OF INITIAL SURGERY: 2018, - BODY PART TO WHICH DEVICE WAS APPLIED: FOOT, - SURGERY DESCRIPTION: CORRECTION, - PATIENT INFORMATION: UNAVAILABLE, - PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE, - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM, - EVENT DESCRIPTION: "PER DR IRA WEINER, DURING A CASE, HE HAD COMPLICATIONS WITH THE AHN. THE END CAP HAS BECOME DETACHED FROM THE BOTTOM OF THE NAIL. X-RAY WAS PROVIDED. THE CASE DID NOT HAVE ANY ADVERSE IMPACT ON THE PATIENT. PATIENT REMAINS NICELY FUSED AND NO ADDITIONAL INTERVENTION IS REQUIRED". 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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8394187 ↗