BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BURR ATTACHMENT-MEDIUM FOR PEN DRIVE

    MDR report key: 3212896 · Received July 9, 2013

    Report

    Report Number
    8030965-2013-04253
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.A SERVICE HISTORY OF THE PAST SIX MONTHS HAS BEEN REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED. THE ITEM HAS NOT PREVIOUSLY BEEN IN FOR SERVICE. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE. (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SERVICE HISTORY OF THE PAST SIX MONTHS FROM THE AWARENESS DATE WAS REVIEWED. THE CUSTOMER'S COMPLAINT THAT THE (756657) SHORT BURR ATTACHMENT WILL NOT SECURE BURRS WAS CONFIRMED. THE DEVICE WAS EVALUATED AND THE COMPLAINT WAS REPRODUCED. THE ROOT CAUSE OF THE FAILURE WAS LIKELY TO HAVE BEEN WORN BEARINGS CAUSED BY EXPOSURE TO ORGANIC DEBRIS AND MATERIALS WHICH LED TO CORROSION AND NORMAL COMPONENT WEAROUT.

    Description of Event or Problem · 1

    ORAL SURGEON WAS DOING A 3RD MOLAR EXTRACTION PROCEDURE ON (B)(6) 2013. WHEN LOADING THE BURR INTO THE HANDPIECE, HE NOTICED THE BURR WAS NOT LOCKING IN PLACE COMPLETELY. HE PROCEEDED TO USE THE DRILL, BUT NOTICED THE ATTACHMENT STARTED GETTING HOT. THE ORAL SURGEON STOPPED USING THE ATTACHMENT AND CHANGED TO ANOTHER ATTACHMENT. HE COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314326 BURR ATTACHMENT-MEDIUM FOR PEN DRIVE HWE SYNTHES GMBH 7562657

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR