BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSTEON WEDGE INTERFERENCE SCREW

    MDR report key: 3952137 · Received May 9, 2014

    Report

    Report Number
    9617083-2014-00016
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    March 20, 2014
    Report Date
    April 16, 2014
    Manufacturer
    BIOCOMPOSITES LTD.
    Product Code
    HWC
    PMA / PMN Number
    K0003641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION AVAILABLE AND FROM VISUAL EXAMINATION OF THE RETURNED DEVICE, THERE WAS NO OBVIOUS DAMAGE TO THE SCREW THREADS OR EXIT HOLE. THE POSSIBLE SUSPECTED ROOT CAUSE OF THE SCREW NOT BEING DRIVEN IS THAT THE INCORRECT DRIVER HAD BEEN USED, HENCE THERE WAS A DRIVER / SCREW FIT ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING ACL CONSTRUCTION SURGERY, IT WAS NOT POSSIBLE TO INSERT THE SCREW BECAUSE THE SCREW DID NOT GRIP. DELAY IN SURGERY TIME OF 5 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282353 BIOSTEON WEDGE INTERFERENCE SCREW BONE SCREW HWC BIOCOMPOSITES LTD. 0913PH298

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention