BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10.0 MM FLIP CUTTER II

    MDR report key: 7074413 · Received December 1, 2017

    Report

    Report Number
    1220246-2017-00455
    Event Type
    Injury
    Date Received
    December 1, 2017
    Date of Event
    October 30, 2017
    Report Date
    December 1, 2017
    Manufacturer
    ARTHREX INC.
    Product Code
    MDM
    UDI-DI
    00888867004115
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. THIS IS ONE OF THREE SUBMISSIONS FROM THE SAME CASE. THE OTHERS ARE CC130078-LINE 213292-00456 AND CC130078-LINE 213294-00457. THE DEVICE WAS RECEIVED AND AN EVALUATION WAS CONDUCTED. THE COMPLAINT WAS CONFIRMED. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THE EVALUATION REVEALED THAT THE INNER SHAFT'S DISTAL END WAS BROKEN OFF. THE SHAFT WAS SLIGHTLY BENT, AND THERE WERE DEEP GOUGING MARKS ON THE DISTAL END OF THE OUTER SHAFT'S SURFACE. ADDITIONALLY, THE INNER SHAFT'S TANG WAS TWISTED. THE DEVICE MET ALL MATERIAL SPECIFICATIONS AS RECEIVED. 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 CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ACL PROCEDURE THREE DIFFERENT FLIP CUTTER II'S WERE ATTEMPTED (AR-1204AF-100: LOT 415148483 {LINE 213291}, LOT 74071209 {LINE 213292} AND AR-1204AF-110: LOT 62316678 {LINE 213294}) AND EACH BROKE INTRA-ARTICULAR WHEN STARTING THE BLIND TUNNEL. BROKEN FRAGMENTS WERE ALL REPORTED TO HAVE BEEN RETRIEVED. THE SURGICAL TECHNIQUE WAS CHANGED FROM AN ACL TO AN ARTHROTOMY AND THE SURGERY WAS COMPLETED SUCCESSFULLY USING ANOTHER MANUFACTURER'S DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854541 10.0 MM FLIP CUTTER II INSTRUMENT, MANUAL, SURGICAL, GENERAL USE MDM ARTHREX INC. 415148483 00888867004115

    Patients

    Seq Age Sex Outcome Treatment
    1 Other