BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSTEON WEDGE INTERFERENCE SCREW

    MDR report key: 3881209 · Received February 11, 2014

    Report

    Report Number
    9617083-2014-00005
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Date of Event
    January 6, 2014
    Report Date
    January 14, 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 WHERE THE DISTAL TIP OF THE RETURNED SCREW WAS MISSING AND THE GUIDE-WIRE EXIT HOLE APPEARED TO BE 'ROUNDED-OUT', THIS CAN OCCUR IF THE SCREW IS DRIVEN OVER A BENT GUIDE-WIRE. THIS WOULD PREVENT THE SCREW ADVANCING INTO THE BONE TUNNEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ACL RECONSTRUCTION SURGERY, THE 9 X 28MM SCREW 'DIDN'T BITE' DURING INSERTION. THERE WAS A DELAY OF 3 MIN. A REPLACEMENT WAS AVAILABLE. THERE WERE NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89519 BIOSTEON WEDGE INTERFERENCE SCREW BONE SCREW HWC BIOCOMPOSITES LTD. 0513PH135

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention