BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K3 ENGINE FILE

    MDR report key: 1192991 · Received October 13, 2008

    Report

    Report Number
    2016150-2008-00098
    Event Type
    Malfunction
    Date Received
    October 13, 2008
    Report Date
    September 24, 2008
    Manufacturer
    SYBRONENDO
    Product Code
    EKS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO INJURIES DUE TO THE REPORTED INCIDENT. THE SUBJECT FILES WERE RETURNED TO SYBRONENDO FOR EVALUATION. THE EVALUATION OF THE FILES INDICATED THAT THE WRONG SIZE FLUTED FILE BLANK WAS CRIMPED TO THE HANDLE. DUE TO THE SMALLER SIZE BLANK THE HANDLE WAS NOT ABLE TO GRIP ONTO THE FILE SHANK. THE RETAIN SAMPLES FROM THE AFFECTED LOT WERE EVALUATED AND WERE DETERMINED TO BE WITHIN SPECIFICATIONS. THERE WAS NO EVIDENCE TO SHOW THAT OTHER FILES HAD THE SAME PROBLEM. THE DEVICE HISTORY RECORD INDICATED THAT THE FINISHED PRODUCTS WERE WITHIN SPECIFICATIONS FOR THE AFFECTED LOT. A REVIEW OF THE COMPLAINT HISTORY FOR THE AFFECTED LOT INDICATED THAT NO PREVIOUS COMPLAINTS HAD BEEN REPORTED. BASED ON THE COMPLAINT HISTORY REVIEW, THE DEVICE HISTORY RECORD AND THE RETAIN SAMPLE CHECK IT HAS BEEN CONCLUDED THAT THIS WAS AN ISOLATED INCIDENT. NO FURTHER ACTION IS NECESSARY. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    ON SEPTEMBER 23, 2008, SYBRONENDO RECEIVED NOTIFICATION FROM A SALES REPRESENTATIVE THAT THE HEADS OF SOME K3 FILES WERE NOT CRIMPED ON TO THE SHAFT, WHICH COULD CAUSE A SERIOUS INJURY IF THE FILES WERE TO BE ASPIRATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 K3 ENGINE FILE FILE, PULP CANAL, ENDODONTIC EKS SYBRONENDO 06F157F

    Patients

    Seq Age Sex Outcome Treatment
    1 Other