BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXLOCK EXTREME NON-LOCKING SCREWS

    MDR report key: 3099506 · Received May 2, 2013

    Report

    Report Number
    3005039508-2013-00007
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 3, 2013
    Manufacturer
    ORTHOHELIX SURGICAL DESIGNS, INC.
    Product Code
    HRS
    PMA / PMN Number
    073624
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THE DESCRIPTION OF THE INCIDENT IS CONSISTENT WITH MECHANICAL DAMAGE OF THE SCREW THREAD CRESTS CAUSED BY CONTACT WITH THE PLATE. THE DRILL GUIDE IN THE SET IS DESIGNED TO HELP CENTER THE PILOT HOLE IN THE PLATE HOLE. SINCE THE DRILL GUIDE WAS NOT USED THE PILOT HOLE MAY HAVE BEEN OFF CENTER IN THE HOLE CAUSING THE SCREW THREADS TO CONTACT THE PLATE AS THE SCREW WAS INSERTED.

    Description of Event or Problem · 1

    DURING INSERTION OF A MFT NON-LOCKING SCREW, THE THREADS OF THE SCREW PEELED OFF THE SCREW SHAFT. IT WAS REPORTED THAT THE SURGEON DID NOT USE A DRILL GUIDE TO INSERT THIS SCREW. THE REP REPORTS THAT THE THREAD FRAGMENT CAME OFF IN ONE PIECE, WAS REMOVED FROM THE PT, AND DISCARDED AND THAT THERE WAS NO EVIDENCE OF ANY FRAGMENTS LEFT IN THE PT. THE SURGEON HAS SINCE SEEN THE PT FOR ROUTINE FOLLOW-UP AND REPORTS THAT THE PT IS "DOING GREAT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191635 MAXLOCK EXTREME NON-LOCKING SCREWS PLATE, FIXATION, BONE HRS ORTHOHELIX SURGICAL DESIGNS, INC. MFT-011-40-35

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention