Centronail Titanium Humeral Nailing System 1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 18032568868487), received between Jul 8, 2016 and Jul 8, 2016 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2016Fracture; Fracture

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6), SURGEON'S NAME: DR. (B)(6); DATE OF INITIAL SURGERY: (B)(6) 2016; BODY PART TO WHICH DEVICE WAS APPLIED: LEFT HUMERAL; SURGERY DESCRIPTION: FRACTURE TREATMENT; PATIENT'S INFORMATION: (B)(6) YEARS OLD, MALE, PREVIOUS HEALTH CONDITION: NORMAL. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM; EVENT DESCRIPTION: DURING THE SURGERY, BOTH DEVICES BROKE BETWEEN THE SCREW HEAD AND BODY AT MOMENT OF DISTAL LOCKING HANDLING. THE BROKEN SCREWS ARE STILL IN THE PATIENT, BECAUSE THE PHYSICIAN EXPECTS TO EXPLANT THEM WHEN THE NAIL REMOVAL WILL BE PERFORMED. NOTE: THE HEAD OF SCREWS ARE AVAILABLE TO RETURN FOR INVESTIGATION. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT; THE SURGERY WAS NOT COMPLETED WITH USED DEVICE; A REPLACEMENT DEVICE WAS IMMEDIATELY AVAILABLE TO COMPLETE SURGERY; THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE -TOTAL DURATION OF THE SURGICAL PROCEDURE: 5. HOURS; THE ESTIMATIVE OF EXTRA TIME NEEDED DUE TO THE SCREWS FAILURE IS 40 MIN. AN ADDITIONAL

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5778549 ↗
• MalfunctionJul 8, 2016Fracture; Fracture

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: HOSPITAL (B)(6), SURGEON'S NAME: DR. (B)(6); DATE OF INITIAL SURGERY: (B)(6) 2016; BODY PART TO WHICH DEVICE WAS APPLIED: LEFT HUMERAL; SURGERY DESCRIPTION: FRACTURE TREATMENT; PATIENT'S INFORMATION: (B)(6), MALE, PREVIOUS HEALTH CONDITION: NORMAL. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM; EVENT DESCRIPTION: DURING THE SURGERY BOTH DEVICES BROKE BETWEEN THE SCREW HEAD AND BODY AT MOMENT OF DISTAL LOCKING HANDLING. THE BROKEN SCREWS ARE STILL IN THE PATIENT, BECAUSE THE PHYSICIAN EXPECTS TO EXPLANT THEM WHEN THE NAIL REMOVAL WILL BE PERFORMED. NOTE: THE HEAD OF SCREWS ARE AVAILABLE TO RETURN FOR INVESTIGATION. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT; THE SURGERY WAS NOT COMPLETED WITH USED DEVICE; A REPLACEMENT DEVICE WAS IMMEDIATELY AVAILABLE TO COMPLETE SURGERY; THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE - TOTAL DURATION OF THE SURGICAL PROCEDURE: 5 HOURS; THE ESTIMATIVE OF EXTRA TIME NEEDED DUE TO THE SCREWS FAILURE IS 40 MIN. AN ADDITIONAL S

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5778537 ↗