BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSURE HA

    MDR report key: 3770613 · Received April 24, 2014

    Report

    Report Number
    1219602-2014-00132
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 29, 2014
    Report Date
    March 31, 2014
    Manufacturer
    MANSFIELD MANUFACTURING SITE
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE BIOSURE HA, 9MM X 30MM WAS RETURNED FOR EVALUATION OF THE REPORTED COMPLAINT MODE, "BROKEN SCREW". NO INFORMATION WAS RECEIVED WITH REGARD TO TUNNEL SIZE OR THE USE OF A STARTER OR TAP. THE REPORTED COMPLAINT WAS CONFIRMED. VISUAL INSPECTION FOUND THE DISTAL TIP TO BE CRACKED. THE DISTAL TIP WAS ALSO FOUND TO BE DEFORMED. THIS MAY BE THE RESULT OF NOT USING THE REQUIRED STARTER FOR THIS DEVICE, OR THE USER MAY HAVE ENCOUNTERED HARDER BONE THAN EXPECTED. PER THE IFU, "USE AN APPROPRIATE SIZE TAP TO PRETAP THE INSERTION SITE PRIOR TO SCREW INSERTION.", AND "IN CASES WHERE HARD BONE IS ENCOUNTERED, IT IS RECOMMENDED THAT A TAP 1 MM LARGER THAN THE SCREW SIZE BE USED.¿ A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED WHICH CONFIRMED NO INCONSISTENCIES. THERE WERE NO INTERNAL PROCESSING ISSUES, WHICH COULD HAVE CONTRIBUTED TO THE NATURE OF THE COMPLAINT. NO ROOT CAUSE RELATED TO THE MANUFACTURE OF THE DEVICE CAN BE ESTABLISHED. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    DURING A TIBIAL TUNNEL PROCEDURE UTILIZING THE BIOSURE HA, 9MM X 30MM, IT WAS REPORTED THAT THE SCREW TIP CRACKED. THE CRACK OCCURRED WHEN SURGEON WAS TWISTING THE SCREW INTO THE TUNNEL OF THE TIBIA. ANOTHER BIOSURE HA WAS USED AS A BACKUP DEVICE. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249686 BIOSURE HA BIOSURE HA, 9MM X 30MM HWC MANSFIELD MANUFACTURING SITE 72201782 50428929

    Patients

    Seq Age Sex Outcome Treatment
    1