BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3171099 · Received June 14, 2013

    Report

    Report Number
    2520274-2013-03398
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Report Date
    May 28, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    HXD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ACTUAL EVENT DATE NOT KNOWN. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. THE INVESTIGATION HAS SHOWN THAT ONE OF THE CLAMPS HOLDING THE CUTTING TOOL IN THE CHUCK ATTACHMENTS IS BROKEN OFF AS COMPLAINED. WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF FAILURE AND WE CAN ONLY ASSUME THAT HIGH VIBRATIONS IN COMBINATION WITH HIGH LOADS COULD HAVE CAUSED THIS OCCURRENCE. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED. CONCLUSION ¿ THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE AS THE INSTRUMENT WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. UNFORTUNATELY THE EXACT CAUSE OF THE BREAKAGE WAS UNABLE TO BE DETERMINED AND THE COMPLAINT CONDITION IS DUE TO AN UNKNOWN CAUSE. NOTE: THIS INSTRUMENT IS CURRENTLY SUBJECTED TO FURTHER INVESTIGATIONS AND OUR PRODUCT DEVELOPMENT CENTER IS WORKING ON IMPROVEMENT MEASURES TO ENHANCE THE DESIGN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE OF THE CLAMPS BROKE. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270302 CHUCK W/KEY F/COMPACT AIR DRIVE+POWER DR HXD SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1