Ankle Compression Nailing System 1 (REF 99-T775100)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18033509858727), received between Mar 6, 2019 and Mar 6, 2019 — classified as 1 injury.

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 18, 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.

• InjuryMar 6, 2019Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: - PRODUCT CODE: AHN CALCANEAL SCREW CODE UNKNOWN. - BATCH NUMBER: UNKNOWN. - QUANTITY: 1. - HOSPITAL NAME: UNKNOWN. - SURGEON NAME: DR. (B)(6). - DATE OF INITIAL SURGERY: UNKNOWN. - 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: "DR (B)(6) REPORTED THAT HE HAD A PATIENT IN THE OFFICE ON (B)(6) 2018 WHERE THE CALCANEAL SCREW HAD BACKED OUT OF THE BONE AND THROUGH THE SKIN. HE PULLED IT OUT REST OF THE WAY OUT". 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 REQUIRED: PERFORMED ON (B)(6) 2018. - COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. - COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE. - PATIENT CURRENT HEALTH CONDITION: PATI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8394188 ↗