BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE BENDING HANDLES

    MDR report key: 3987806 · Received July 28, 2014

    Report

    Report Number
    1651501-2014-00032
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THIS IS THE SECOND REPORT OF TWO REPORTS CONCERNING THE SAME SURGERY AND SAME SURGEON (SEE MFR REPORT NUMBER 1651501-2014-00031). THIS REPORT CONCERNS THE PLATE BENDING HANDLES (PRODUCT ID PBH-5010-01). IT WAS REPORTED DURING A RIGHT ANKLE FUSION SURGERY, THE SURGEON ATTEMPTED TO USE THE "ANTERIOR FUSION PLATE AND WAS UNABLE TO BEND THE PLATE TO FIT THE PATIENT ANATOMY. DUE TO THIS HE TRIED TO IMPLANT THE DEVICE AND IT CAUSED THE DISTRACTION OF THE POSTERIOR TALOR SPACE. HE THEN DECIDED TO CUT THE PLATE BELOW THE MOST PROXIMAL HOLE." THE SURGERY TIME WAS INCREASED BY 1 HOUR." ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON WHO REPORTED HE "CUT THE PLATE WITH THE PLATE BANDER AND CUT HIS RIGHT INDEX FINGER WITH THE PLATE SHARDS CAUSED BY THE SCREW-IN PLATE BENDERS THAT STRIPPED LOCKING SLOTS." BETADINE WAS APPLIED TO HIS FINGER, HIS GLOVES WERE CHANGED AND HIS FINGER WAS REPORTED AS "HEALED BUT SENSITIVE". THE SURGEON WAS ABLE TO COMPLETE THE SURGERY. ON (B)(6) 2014 ADDITIONAL INFORMATION WAS RECEIVED FROM THE REPRESENTATIVE WHO WAS PRESENT AT THE SURGERY. HE STATED THE SURGEON 'POKED HIMSELF' WITH THE THREAD OF THE PLATE WHEN HE USED THE PLATE BENDER. THE SURGEON CHANGED GLOVES AND USED A DIFFERENT (SPARE) PLATE TO IMPLANT IN THE PATIENT AND TO COMPLETE THE SURGERY. THERE WAS NO REPORTED ISSUES WITH THE SPARE PLATE. THERE WAS NO REPORTED INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439927 PLATE BENDING HANDLES NONE LXH ASCENSION ORTHOPEDICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention