Ankle Compression Nailing System 1 (REF 99-T774022)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18054242511564), received between Apr 23, 2019 and Apr 23, 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 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.

• MalfunctionApr 23, 2019Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON'S NAME: DR. (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2019 BODY PART TO WHICH DEVICE WAS APPLIED: FOOT/ANKLE/TIBIA LEFT. SURGERY DESCRIPTION: N/A. PATIENT INFORMATION: 30 YEAR-OLD, FEMALE, WEIGHT NORMAL. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE . TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: DRIVER FOR LOCKING THE TALUS SCREW FOUND NO CONTACT TO LOCK IT. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT, THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE AN ADDITIONAL SURGERY WAS NOT REQUIRED FOLLOWING DEVICE FAILURE, A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED, COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE , COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE. FURTHER INFORMATION RECEIVED FROM THE DISTRIBUTOR ON 27 MARCH 2019: THE SURGERY COULD BE ENDED WELL. THE SURGERY PROCEDURE LASTED ½ HOUR MORE. X-RAYS AND PATIENT CURRENT HEALTH CONDITION ARE REQUESTED. THE COMPRESSION OF THE SCREW WAS STRONG ENOUGH TO HOLD THE SCREW IN PLACE. NAIL AND SCREW ARE IN THE PATIENT. FURTHER INFORMATION RECEIVED FROM

  Patient problems: No Code Available

  MAUDE report 8539326 ↗