BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHUCK W/KEY F/COMPACT AIR DRIVE+POWER DR

    MDR report key: 3160565 · Received June 10, 2013

    Report

    Report Number
    8030965-2013-03049
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    June 20, 2012
    Report Date
    June 20, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE VISUAL INVESTIGATION HAS SHOWN THAT ONE OF THE CLAMPS HOLDING THE CUTTING TOOL IN THE CHUNK ATTACHMENT IS BROKEN OFF AS COMPLAINED. THE REVIEW OF THE PRODUCTION HISTORY REVEALED THAT THIS INSTRUMENT WAS MANUFACTURED IN NOVEMBER 2011 ACCORDING TO THE SPECIFICATIONS. NO ABNORMAL FINDINGS WERE IDENTIFIED. THE INSTRUMENT WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF FAILURE; WE CAN ONLY ASSUME THAT HIGH VIBRATION IN COMBINATION WITH HIGH LOADS COULD HAVE CAUSED THIS OCCURRENCE. THE COMPLAINT WAS DETERMINED TO BE INDETERMINATE.

    Description of Event or Problem · 1

    THE SURGEON REALIZED THAT THE CHUNK IS FALLEN APART, HE IS NOT ABLE TO USE IT, BECAUSE THE TEETH HAVE FALLEN OUT. THE OPERATION WAS FINISHED WITH ANOTHER CHUCK SUCCESSFULLY THIS IS 1 OF 1 REPORT FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259981 CHUCK W/KEY F/COMPACT AIR DRIVE+POWER DR HWE SYNTHES GMBH 7645370

    Patients

    Seq Age Sex Outcome Treatment
    1