BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING THIRD TUBULAR PLATE, SS, 4H

    MDR report key: 3834412 · Received May 28, 2014

    Report

    Report Number
    1220246-2014-00084
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 30, 2014
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    PMA / PMN Number
    K123241
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE WAS REQUESTED FOR EVALUATION BUT PART REMAINS IN THE PATIENT AND CANNOT BE RETURNED THEREFORE THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. LOT NUMBER WAS NOT PROVIDED SO DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED. A MOST LIKELY CAUSE IS AS STATED IN THE EVENT THAT THE SURGEON MAY HAVE DRILLED OFF-CENTER AT AN ANGLE, POSSIBLY HITTING INTO THE PLATE. THEN AS HE TIGHTENED DOWN THE TIGHT ROPE, THE PLATE BROKE AND THE BUTTON PULLED THROUGH CAUSING THE BONE TO CRACK. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. PART REMAINS IN PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SYNDESMOSIS ANKLE REPAIR, THE ANTERIOR PART OF THE PLATE BROKE WHERE THE PROXIMAL TIGHT ROPE IS PLACED. THE SURGEON REDRILLED AND INSERTED ANOTHER TIGHTROPE WHICH WAS PLACED IN THE PLATE. THE FIRST TIGHT ROPE THAT WAS PLACED BROKE THROUGH THE ANTERIOR PART OF THE PLATE AND BROKE THE FIBULA WHEN THE SURGEON WAS TIGHTENING IT DOWN. THE PLATE HAD NOT BEEN BENT PRIOR TO INSERTION. FOLLOW UP INFORMATION: ANOTHER TIGHTROPE WAS USED TO COMPLETE THE CASE. PER REP, SURGEON STATED HE MAY HAVE DRILLED OFF CENTER AT AN ANGLE, POSSIBLY HITTING INTO THE PLATE. THEN AS HE TIGHTENED DOWN THE TIGHT ROPE, THE PLATE BROKE AND THE BUTTON PULLED THROUGH CAUSING THE BONE TO CRACK. PT IS DOING FINE TO DATE. REPAIR IS SECURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313605 LOCKING THIRD TUBULAR PLATE, SS, 4H PLATE, FIXATION, BONE HRS ARTHREX, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other