BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0 MM FLIP CUTTER II

    MDR report key: 3203687 · Received July 3, 2013

    Report

    Report Number
    1220246-2013-00117
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    May 15, 2013
    Report Date
    June 12, 2013
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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 WAS NOT 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. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. COMPLAINANT'S EVENT TYPICALLY CAUSED BY USER MECHANICAL DAMAGE TO DEVICE SUCH AS HITTING THE DEVICE WITH ANOTHER DEVICE, PRYING/LEVERAGING OR EXCESSIVE BENDING FORCES BEING APPLIED DURING USE. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. 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. DEVICE NOT YET SENT BACK BY FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 FLIP CUTTERS BROKE DURING TIBIAL SOCKET DRILLING IN A REVISION ACL. ETHIBOND SUTURE WAS PRESENT IN SOCKET, FROM PREVIOUS ACL REPAIR WAS STILL IN THE AREA BEING DRILLED. FRAGMENTS OF DEVICE WERE NOT REMOVED AND REMAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304514 11.0 MM FLIP CUTTER II INSTRUMENT, MANUAL, SURGICAL, GENERAL USE MDM ARTHREX, INC. 234038492

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other