BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTEOSITE STERILE SCREW, 120/30, 4.5/3.5 MM

    MDR report key: 1025273 · Received April 1, 2008

    Report

    Report Number
    2183449-2008-00002
    Event Type
    Malfunction
    Date Received
    April 1, 2008
    Date of Event
    February 6, 2008
    Report Date
    March 27, 2008
    Manufacturer
    ORTHOFIX SRL
    Product Code
    HWC
    PMA / PMN Number
    K974186
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO ORTHOFIX MEDICAL DIRECTOR, DR. THE 99-60138 BONE SCREW WAS INCORRECTLY CHOSEN BY THE SURGEON TO TREAT THE PT. THE ORTHOFIX INSTRUCTION FOR USE CLEARLY DEFINES THE TYPES OF BONE SCREWS TO BE USED IN DIFFERENT SITUATIONS. IN AN ADULT TIBIA, THE SURGEON SHOULD HAVE USED 6.0 - 5.6 MM XCALIBER SCREWS. THE SCREW HAS BEEN RETURNED TO THE MFR AND IS CURRENTLY UNDER TECHNICAL EVAL, HOWEVER, AT THIS TIME, THIS INCIDENT IS CLEARLY A CASE OF SURGEON ERROR. IN AS MUCH AS THE SURGEON WAS SEEMINGLY UNAWARE THAT HE WAS EMPLOYING AN INCORRECT SCREW SIZE FOR THIS PT, ORTHOFIX WILL REINFORCE THE RECOMMENDED SCREW SELECTION CRITERIA TO THE SURGEON.

    Description of Event or Problem · 1

    THE TIP OF THE 99-60138 SCREW BROKE OFF IN THE PT DURING INSERTION. SCREW TIP WAS LEFT IN SITU AS THE SURGEON BELIEVED THERE WAS NO WAY TO REMOVE THE THREADED PORTION WITHOUT COMPLICATING THE SURGERY. THE SURGEON SELECTED AN ALTERNATE SITE FOR SCREW PLACEMENT AND ANOTHER 99-60138 BONE SCREW WAS USED TO COMPLETE THE PROCEDURE. TWO ADD'L SCREWS OF THE SAME SIZE WERE PLACED IN THE SAME MANNER WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEOSITE STERILE SCREW, 120/30, 4.5/3.5 MM STERILE HYDROXYAPATITE COATED SCREW HWC ORTHOFIX SRL 99-60138 G040

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR