BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO-LINE STRAIGHT HDPC 1:1 ROUND SHAFT

    MDR report key: 6656664 · Received June 21, 2017

    Report

    Report Number
    9610612-2017-00333
    Event Type
    Malfunction
    Date Received
    June 21, 2017
    Date of Event
    May 30, 2017
    Report Date
    July 19, 2017
    Manufacturer
    AESCULAP AG
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: (B)(6). THE HANDPIECE HEATED CREATING A BURN AT THE LEVEL ON THE LEFT CORNER OF THE PATIENT. THE PATIENT WAS OPERATED ON FOR A REMOVAL OF THE LEFT MANDIBLE PLATE. WHICH REQUIRES MILLING WITH A VERY THIN TUNGSTEN BALL WHICH IS ENGAGED ON THE HANDPIECE. THE ABOVE HEATED VERY QUICKLY (THERE WAS LESS THAN 10 MINUTES OF INTERVENTION). COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: GB109 / MICRO-LINE STRAIGHT HDPC 1:1 ROUND SHAFT. GD678 / MICROSPEED UNI MICRO 150 MOTOR. GD672 / MICROSPEED UNI MOTOR CABLE F/FOOT CTRL.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE INVESTIGATION WAS CARRIED OUT BY THE AESCULAP TECHINCAL SERVICE DEPARTMENT (ATS). A FUNCTIONAL TEST COULD NOT BE PERFORMED. IT WAS NOT POSSIBLE TO ADAPT A TOOL. LOUD RUNNING NOISES CAN BE HEARD. AFTER THE DISASSEMBLY OF THE HANDPIECE, A BROKEN BALL BEARING CAN BE FOUND. FURTHERMORE THE INTERIOR IS SOILED. THE BORE AT THE CASE HAS BEEN MODIFIED. THE SUPPLIED MILL (UNKNOWN MANUFACTURER DUE TO A MISSING ENGRAVING) SHOWS ABRASION AT THE SHAFT. THIS ABRASION CAN GET INTO THE HANDPIECE DURING USE. FURTHERMORE, THE CUTTING EDGES ARE EXTREMELY DAMAGED. WITH SUCH A MILL A PROPER WORKING IS NOT POSSIBLE AND REQUIRES HIGH EFFORT AND LOAD DURING USE. DUE TO THE STAINING AT THE INTERIOR AS WELL AS THE BROKEN BALL BEARING, A HIGH TEMPERATURE DEVELOPMENT CAN BE OBSERVED. BATCH HISTORY REVIEW: A REVIEW OF THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS WAS NOT POSSIBLE BECAUSE THE DEVICE IS A PURCHASED PART. CONCLUSION AND ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF OUR INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY RELATED TO AN INSUFFICIENT HANDLING AND MAINTENANCE OF THE DEVICE. NO CAPA IS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436805 MICRO-LINE STRAIGHT HDPC 1:1 ROUND SHAFT HIGH SPEED POWER SYSTEMS HWE AESCULAP AG GB109

    Patients

    Seq Age Sex Outcome Treatment
    1 Other GB109 / MICRO-LINE STRAIGHT HDPC 1:1 ROUND SHAFT| GD672 / MICROSPEED UNI MOTOR CABLE F/FOOT CTRL.| GD678 / MICROSPEED UNI MICRO 150 MOTOR| GB109 / MICRO-LINE STRAIGHT HDPC 1:1 ROUND SHAFT| GD672 / MICROSPEED UNI MOTOR CABLE F/FOOT CTRL.| GD678 / MICROSPEED UNI MICRO 150 MOTOR