BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAD II

    MDR report key: 4094017 · Received September 16, 2014

    Report

    Report Number
    8030965-2014-01390
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    October 23, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES SERVICE AND REPAIR FILES LEGACY REVIEW/REMEDIATION PROTOCOL-COMPLAINT HANDLING AND MDR REPORTING. 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. DURING PRE-REPAIR ASSESSMENT PERFORMED BY TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED THE DEVICE WAS NOT FUNCTIONING. THIS WAS CONTRIBUTED TO IMPROPER MAINTENANCE OF THE DEVICE. DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER ON (B)(4) 2012. PLACEHOLDER.

    Description of Event or Problem · 1

    THE COMPACT AIR DRIVE (CAD) WAS RETURNED FOR SERVICE. IT WAS REPORTED THAT THE BEARINGS AND PUSH BUTTON WERE WORN. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573662 CAD II HWE SYNTHES GMBH 22876

    Patients

    Seq Age Sex Outcome Treatment
    1