BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO-LINE STRAIGHT HDPC 1:1 F/2. 35X70MM

    MDR report key: 3850754 · Received March 20, 2014

    Report

    Report Number
    2916714-2014-00194
    Event Type
    Malfunction
    Date Received
    March 20, 2014
    Report Date
    March 20, 2014
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON: (B)(4) 2014. MANUFACTURING SITE EVALUATION: THE HANDPIECE WAS RECEIVED WITH AN INSERTED TOOL (BURR) FROM A NON-AESCULAP MANUFACTURER. THE HANDPIECE IS VISUALLY IN GOOD SHAPE. THE TOOL ACCEPTOR PART AS WELL AS THE TOOL LOCKING MECHANISM IS WORKING CORRECTLY. DURING THE FUNCTIONAL INSPECTION (RUNNING TEST WITHOUT LOAD), RUNNING NOISE COULD BE DETECTED. AN UNUSUAL WARMING OF THE PRODUCT COULD NOT BE DETECTED, SO THE TEMPERATURE BEHAVIOR IS NOT REMARKABLE. THE DEVICE WAS DISASSEMBLED AND IT WAS DETECTED THAT THE BALL BEARINGS ARE DAMAGED (CAUSING THE DESCRIBED RUNNING NOISE). NO ABRASIONS WERE NOTED. THE RECEIVED FOREIGN TOOL (BURR) IS MASSIVELY DEFORMED AT THE WORKING END. ACCORDING TO THE INFORMATION IN THE SYSTEM, THE PRODUCT WAS REPAIRED BY THE ATS TEAM UK IN JULY 2013. THE DOCUMENTATION OF THE LAST REPAIR SHOWS THAT THE BALL BEARING GD450216 (BALL BEARING IN THE TIP) WAS EXCHANGED. OTHER COMPONENTS WERE NOT CHANGED. IT IS VERY LIKELY THAT THE HEATING AND BURN WERE CAUSED BY THE DAMAGED TOO USED, MOST LIKELY IN COMBINATION WITH HIGH LATERAL FORCE. NO PRODUCT DEFECTS WERE FOUND RELATED TOT HE DESCRIBED FAILURE. THE TOOL (BURR) THAT WAS RECEIVED (NON-AESCULAP) IS NOT SUITABLE FOR THE HANDPIECE. THIS HAS LIKELY NEGATIVELY INFLUENCED THE WARMING BEHAVIOR OF THE HANDPIECE. OTHER COMPONENTS IN USE AT TIME OF INCIDENT INCLUDE; GD670 MICROSPEED UNI - GD668, MICROSPEED UNI FOOT CONTROL ONE PEDAL - GD460R, SPRAY NOZZLE FOR GD450R/GD455R/GD465 - GD672, MICROSPEED UNI MOTOR CABLE F/FOOT CTRL. - GD678, MICROSPEED UNI MICRO 150 MOTOR. EACH DEVICE WAS FOUND TO BE ACCORDING TO SPECIFICATION AND DID NOT CONTRIBUTE TO THE INCIDENT.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). DRILL OVERHEATED AND BURN PATIENTS LIP AND INSIDE OF MOUTH CAUSING FULL THICKNESS MUCOSAL BURN. BURN WAS NOT CAUSED BY DRILL BIT OR BURR BUT BY DRILL ITSELF. THE SECTION OF THE DRILL HELD BY THE SURGEON DIDN'T GET HOT SO HE WAS UNAWARE OF IT GETTING IT HOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167583 MICRO-LINE STRAIGHT HDPC 1:1 F/2. 35X70MM SURGICAL DRILL HANDPIECE HWE AESCULAP AG & CO. KG GD450M 12-1003755

    Patients

    Seq Age Sex Outcome Treatment
    1 Other