Orthofix External Fixation Screw (Pin) with Hydroxyapatite coating 1 (REF 99-612670)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18032568862195), received between Aug 30, 2017 and Aug 30, 2017 — classified as 1 injury.

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

• InjuryAug 30, 2017Fracture; Fracture

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: - HOSPITAL NAME: (B)(6), - SURGEON'S NAME: DR. (B)(6), - DATE OF SURGERY: (B)(6) 2017, - BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR, - SURGERY DESCRIPTION: FRACTURE TREATMENT, - PATIENT INFORMATION: (B)(6), MALE, - PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE, - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM, - EVENT DESCRIPTION: "PATIENT HAS BEEN TREATED DUE TO POLYTRAUMATISM. A GALAXY KIT HAS BEEN USED. FIRST SCREW WAS FIXED WITHOUT ISSUE. WHEN INSERTING SECOND ONE, IT GOT BROKEN NEARBY SECOND CORTICAL. HEAD AND THREAD PART KEPT IN FIRST CORTICAL AND MEDULLARY CANAL. SCREW WAS INTRODUCED HANDLY WITH PRE-DRILLING AT 4.8 MM". THE COMPLAINT REPORT FORM ALSO INDICATES: - THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: MULTIPLE INCISIONS TO RETRIEVE SCREW FRAGMENTS AND PROLONGATION OF SURGERY TIME. UN-RETRIEVED DEVICE FRAGMENTS. - THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. - THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE: DRILLING IN ORDER TO SORT OUT SCREW FRAGMENT. - AN ADDITIONAL SURGERY WAS NOT REQUIRED. - A MEDICAL INTERVENTION WAS NOT REQUIRED. - CO

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 6829538 ↗